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Beckman Coulter Recalls
332 recalls on record · August 29, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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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.
January 10, 2018Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitativ
Hazard: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
January 10, 2018Medical DevicesFDA
Beckman Coulter Inc. recalls Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitat
Hazard: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
January 10, 2018Medical DevicesFDA
Beckman Coulter Inc. recalls Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quanti
Hazard: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
December 20, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
Hazard: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
December 20, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the D
Hazard: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
December 20, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Hazard: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
November 22, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.
Hazard: The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
November 1, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Hazard: Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.
September 27, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for
Hazard: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
September 20, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnosti
Hazard: Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
September 13, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patien
Hazard: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
September 13, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematolog
Hazard: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
September 6, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allo
Hazard: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
July 19, 2017Medical DevicesFDA
Beckman Coulter Inc recalls Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K,
Hazard: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
July 12, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the CO
Hazard: When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
July 12, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting
Hazard: When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
July 5, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Hazard: The Access immunoassays are susceptible to biotin interference.
July 5, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Access System-Free T4 Assay, B01902E, Catalog No. 33880
Hazard: The Access immunoassays are susceptible to biotin interference.
July 5, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Access Thyroglobulin, A34085G, Catalog No. 33860
Hazard: The Access immunoassays are susceptible to biotin interference.
July 5, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Access Total T3, A34435H, Catalog No. 33830
Hazard: The Access immunoassays are susceptible to biotin interference.
May 31, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
Hazard: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
May 31, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Hazard: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
May 31, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel Dx
Hazard: Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentra
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides conc
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentr
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creat
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concen
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
May 24, 2017Medical DevicesFDA
Beckman Coulter Inc. recalls Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentratio
Hazard: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.