REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Reported: August 11, 2021 Initiated: June 10, 2021 #Z-2187-2021
Product Description
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Reason for Recall
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 2,212 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of VA, UT, TX, TN, SD,PA, NY, ME, ID, CA and the countries of AFGHANISTAN, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVI, CANADA, CAYMAN ISLANDS, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FAROE ISLAND, FINLAND, FRANCE, GERMANY, GREENLAND, Hong Kong, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, MONTENEGRO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL, PR CHINA, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UNITED KINGDOM, VIETNAM.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866. Recalled by Abbott Laboratories. Units affected: 2,212 units.
Why was this product recalled? ▼
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 11, 2021. Severity: Moderate. Recall number: Z-2187-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11