Recall Atlas
Drugs & medicalClass III

Abbott Ireland Limited recalls Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

Read the official notice →
Date
2023-06-14
Country
United States
Brand
Abbott Ireland Limited
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Classification
Class III
Units
US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

  1. 2023-06-21
  2. US
    Drugs & medicalClass III

    Amring Pharmaceuticals Inc recalls Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn,…

    Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

    FDA · DrugAmring Pharmaceuticals IncNationwide in the USA.Official notice →
  3. 2023-06-14
  4. US
    Drugs & medicalClass II

    C.R. Bard Inc recalls HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF…

    Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

    FDA · DeviceC.R. Bard IncWorldwideOfficial notice →
  5. US
    Drugs & medicalClass II

    Young Dental Manufacturing I, LLC recalls BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

    FDA · DeviceYoung Dental Manufacturing I, LLCUS distribution to Florida, Nevada, and Pennsylvania.Official notice →
  6. US
    Drugs & medicalClass III

    Mechatronics USA recalls RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the…

    QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

    FDA · DeviceMechatronics USAWorldwide distribution - US Nationwide distribution in the state of OH and the…Official notice →
  7. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05,…

    The custom procedure packs contain light handle covers that have been recalled by another firm.

    FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the state of VA.Official notice →
  8. US
    Drugs & medicalClass II

    Cardinal Health 200, LLC recalls Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

    Inadvertently released for distibution without sterility assurance.

    FDA · DeviceCardinal Health 200, LLCDistribution in the US to GeorgiaOfficial notice →
See all drugs & medical recalls →