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Abbott Laboratories Recalls
156 recalls on record · June 27, 2012 to December 24, 2025 · Drugs, Food & Beverage, Medical Devices
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 17, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In
Hazard: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
April 10, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Hazard: The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
April 10, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Hazard: The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
April 10, 2019Medical DevicesFDA
Abbott Laboratories recalls CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vi
Hazard: There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
March 13, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in hu
Hazard: Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
August 1, 2018Medical DevicesFDA
Abbott Laboratories, Inc. recalls CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital
Hazard: Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
March 14, 2018Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There
Hazard: There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
March 14, 2018Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There ar
Hazard: There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
March 14, 2018Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There ar
Hazard: There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
November 29, 2017Medical DevicesFDA
Abbott Laboratories, Inc recalls Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Hazard: The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
November 29, 2017Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemi
Hazard: The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
October 18, 2017Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park,
Hazard: There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
June 28, 2017Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quanti
Hazard: Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
March 15, 2017Medical DevicesFDA
Abbott Laboratories recalls CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated h
Hazard: The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
November 16, 2016Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human pla
Hazard: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
June 8, 2016Medical DevicesFDA
Abbott Laboratories recalls The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Hazard: Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
April 27, 2016Medical DevicesFDA
Abbott Laboratories recalls CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is design
Hazard: Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
November 4, 2015Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT syste
Hazard: Incorrect tubing.
July 29, 2015Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro dia
Hazard: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
July 8, 2015Medical DevicesFDA
Abbott Laboratories recalls ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Hazard: ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
June 17, 2015Medical DevicesFDA
Abbott Laboratories recalls Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL
Hazard: The product is leaking from the cap and crystallization was noted as present around the cap.
March 18, 2015Food & BeverageFDA
Abbott Laboratories recalls Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
Hazard: The firm received three consumer calls of product with Chinese labeling. After an internal investigation, the firm discovered that product manufactured for export to China was distributed to three states in the US. All labeling is in Chinese.
November 5, 2014Medical DevicesFDA
Abbott Laboratories recalls HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized
Hazard: HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
November 5, 2014Medical DevicesFDA
Abbott Laboratories, Inc recalls Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Hazard: Package inserts have incorrect SmartWash parameters for Triglyceride.
June 4, 2014Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buff
Hazard: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In
June 4, 2014Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with
Hazard: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In
October 23, 2013Medical DevicesFDA
Abbott Laboratories, Inc recalls Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum
Hazard: Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
April 24, 2013Medical DevicesFDA
Abbott Laboratories, Inc recalls Clinical Chemistry Phenobarbital, list number 1E08
Hazard: Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
April 3, 2013Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54
Hazard: Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR
January 30, 2013Medical DevicesFDA
Abbott Laboratories recalls Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35
Hazard: The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.