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…

Read the official notice →
Date
2022-05-04
Country
United States
Brand
Instrumentation Laboratory
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…
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Argentina,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-11-29
  2. 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 →
  3. 2023-09-20
  4. 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 →
  5. 2023-04-05
  6. US
    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

    FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Albania,…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. 2021-12-01
  10. 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 →
  11. 2021-10-27
  12. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low…

    Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

    FDA · DeviceInstrumentation LaboratoryUS Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil…Official notice →
All 14 Instrumentation Laboratory recalls →

Other drugs & medical recalls in the United States

  1. 2022-05-11
  2. US
    Drugs & medicalClass II

    SCA Pharmaceuticals recalls Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

    CGMP Deviations

    FDA · DrugSCA PharmaceuticalsProduct was distributed nationwide within the United StatesOfficial notice →
  3. 2022-05-04
  4. US
    Drugs & medicalClass II

    Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

    Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

    FDA · DeviceFreudenberg Medical, LlcUS distribution: GA, OH Foreign distribution: NetherlandsOfficial notice →
  5. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number…

    Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →
  6. US
    Drugs & medicalClass II

    Waters Medical Systems LLC recalls WAVES WCM Kidney Cassette Module

    There is a potential for the WCM cassette pump head leaking solution.

    FDA · DeviceWaters Medical Systems LLCWCM cassettes have been distributed to one domestic customer with two…Official notice →
  7. US
    Drugs & medicalClass II

    Draegar Medical Systems, Inc. recalls Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless…

    Software issue resulting in temporary loss of central monitoring functionality.

    FDA · DeviceDraegar Medical Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  8. US
    Drugs & medicalClass II

    Stryker GmbH recalls Smart Toe II Intramedullary Arthrodesis Implant

    The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with…

    FDA · DeviceStryker GmbHWorldwide distribution - US Nationwide and the countries including Australia,…Official notice →
See all drugs & medical recalls →