Drugs & medicalClass II

Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Read the official notice →
Date
2023-04-05
Country
United States
Brand
Instrumentation Laboratory
Product
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis…
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Canada, Albania,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Instrumentation Laboratory recalls

  1. 2025-02-05
  2. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

    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.

    FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Andorra, Algeria, Armenia,…Official notice →
  3. 2023-11-29
  4. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

    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…

    FDA · DeviceInstrumentation LaboratoryUS States: MA, MN, NY. India.Official notice →
  5. 2023-09-20
  6. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or…

    Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

    FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Finland,…Official notice →
  7. 2022-05-18
  8. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls HemosIL ReadiPlasTin, Part No. 0020301400

    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…

    FDA · DeviceInstrumentation LaboratoryUS Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS,…Official notice →
  9. 2022-05-04
  10. US
    Drugs & medicalClass II

    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 00000280060R…

    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…

    FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  11. 2021-12-01
  12. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

    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…

    FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →
All 14 Instrumentation Laboratory recalls →

Other drugs & medical recalls in the United States

  1. 2023-04-05
  2. US
    Drugs & medicalClass II

    Iradimed Corporation recalls Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

    Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which…

    FDA · DeviceIradimed CorporationWorldwide distribution - US Nationwide and the countries of Austria, Canada,…Official notice →
  3. US
    Drugs & medicalClass II

    Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund…

    The incorrect IFU was distributed with the devices.

    FDA · DeviceElekta Instrument ABUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS,…Official notice →
  4. US
    Drugs & medicalClass II

    Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…

    Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

    FDA · DeviceQuidel Corporationnot yet availableOfficial notice →
  5. US
    Drugs & medicalClass II

    Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400

    The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the…

    FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice →
  6. US
    Drugs & medicalClass II

    Entopsis , Inc. recalls PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000…

    Presence of misleading label statements on the product label.

    FDA · DeviceEntopsis , Inc.Nationwide and Canada, UK, Portugal, England, Spain, England , Germany,…Official notice →
  7. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item…

    Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the…

    FDA · DeviceZimmer, Inc.AL AZ CO FL LA MI OH OK TX Foreign: CanadaOfficial notice →
See all drugs & medical recalls →