Drugs & medicalClass II

Abbott GmbH recalls ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results…

Read the official notice →
Date
2024-04-10
Country
United States
Brand
Abbott
Product
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Classification
Class II
Units
US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Abbott recalls

  1. 2025-10-22
  2. US
    Drugs & medicalClass I

    Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

    Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

    FDA · DeviceAbbottWorldwideOfficial notice →
  3. 2025-04-30
  4. US
    Drugs & medicalClass II

    Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

    Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with…

    FDA · DeviceAbbottWorldwide - US Nationwide distribution.Official notice →
  5. 2024-06-14
  6. UK
  7. 2023-11-08
  8. US
    Drugs & medicalClass II

    Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

    Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.

    FDA · DeviceAbbottUS, Taiwan, and ColombiaOfficial notice →
  9. 2023-07-19
  10. US
    Drugs & medicalClass I

    Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

    FDA · DeviceAbbottWorldwide distribution - US Nationwide and the countries of Slovakia, Czech…Official notice →
  11. 2022-10-14
  12. CA
    Food & drinkClass 3

    Abbott brand Similac Sterilized Water recalled due to spoilage

    Non harmful (quality or spoilage)

All 15 Abbott recalls →

Other drugs & medical recalls in the United States

  1. 2024-04-17
  2. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc.,…

    Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

    FDA · DrugTeva Pharmaceuticals USA, IncNationwide in the USAOfficial notice →
  3. US
  4. US
  5. 2024-04-10
  6. US
    Drugs & medicalClass II

    Navinetics Inc recalls NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically…

    FDA · DeviceNavinetics IncUS Nationwide distribution in the states of FL, MN, CO.Official notice →
  7. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

    Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument…

    FDA · DeviceWright Medical Technology, Inc.US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE,…Official notice →
  8. US
    Drugs & medicalClass II

    Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

    The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis…

    FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice →
See all drugs & medical recalls →