The Recall Desk

Manufacturer

Instrumentation Laboratory

38 recalls in our database name Instrumentation Laboratory as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–38 of 38

  • HighFDA (Devices)·Z-0359-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings

    Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0358-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors

    The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2578-2023·2023-09-20

    Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification

    Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.

    Product
    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2023·2023-04-05

    ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.

    Product
    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2023·2023-04-05

    FDA recalls ACL ELITE refurbished analyzer to remove Anti-Xa test

    Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.

    Product
    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1307-2023·2023-04-05

    ACL ELITE PRO analyzer test definition removal for Anti-Xa reagent

    Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.

    Product
    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1305-2023·2023-04-05

    ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.

    Product
    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2022·2022-05-18

    Prothrombin Time Reagent Recalled for Quality Control Failures

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.

    Product
    HemosIL ReadiPlasTin, Part No. 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2022·2022-05-04

    ACL TOP Laboratory Analyzer Carryover Contamination May Affect Test Results

    Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.

    Product
    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 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 55
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2022·2021-10-27

    Anti-Xa Assay On-Board Stability Reduced from 7 to 5 Days

    The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.

    Product
    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0151-2022·2021-10-27

    HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2022·2021-10-27

    Heparin Activity Assay Labeling Correction: Reduced On-Board Stability

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
Instrumentation Laboratory recalls · The Recall Desk