Home / Brands / Instrumentation Laboratory
Instrumentation Laboratory Recalls
77 recalls on record · September 26, 2012 to August 12, 2026 · Medical Devices
Recalls by year
12
13
14
16
18
19
21
22
23
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 20, 2025Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls; Part Number: 0020300200;
Hazard: Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
February 5, 2025Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Hazard: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
September 20, 2023Medical DevicesFDA
Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulati
Hazard: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
April 5, 2023Medical DevicesFDA
Instrumentation Laboratory recalls ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation
Hazard: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
April 5, 2023Medical DevicesFDA
Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/
Hazard: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
April 5, 2023Medical DevicesFDA
Instrumentation Laboratory recalls ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri
Hazard: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
April 5, 2023Medical DevicesFDA
Instrumentation Laboratory recalls ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol
Hazard: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
May 18, 2022Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL ReadiPlasTin, Part No. 0020301400
Hazard: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
May 4, 2022Medical DevicesFDA
Instrumentation Laboratory recalls ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS
Hazard: Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
December 1, 2021Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Hazard: The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
October 27, 2021Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a
Hazard: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
October 27, 2021Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical
Hazard: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
October 27, 2021Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a
Hazard: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
September 18, 2019Medical DevicesFDA
Instrumentation Laboratory Co. recalls ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Hazard: Prolonged clotting times
September 18, 2019Medical DevicesFDA
Instrumentation Laboratory Co. recalls ROTEM ex-tem Canada Part No: 503-05-CA
Hazard: Prolonged clotting times
September 18, 2019Medical DevicesFDA
Instrumentation Laboratory Co. recalls ROTEM ex-tem; US Part No: 503-05-US
Hazard: Prolonged clotting times
October 17, 2018Medical DevicesFDA
Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagno
Hazard: There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
March 14, 2018Medical DevicesFDA
Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Hazard: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
February 10, 2016Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptoki
Hazard: This Lot is not meeting labeled on-board instrument stability claims of 5 days.
December 31, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reage
Hazard: Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 300 CTS, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700 CTS, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 500 CTS, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700 LAS, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP CTS, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700, automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.
July 23, 2014Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP (Base), automated coagulation laboratory instrument.
Hazard: Potential for sample misidentification.