Home / Recalls / Abbott Laboratories / Z-2187-2021

Z-2187-2021 Class II Ongoing

Recalled by Abbott Laboratories — Irving, TX

FDA device recall Z-2187-2021 was initiated by Abbott Laboratories on June 10, 2021 and is designated Class II. 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 sam… The recall status is ongoing. Affected quantity: 2,212 units.

Recall Details

Product Type
Devices
Report Date
August 11, 2021
Initiation Date
June 10, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,212 units

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

Distribution Pattern

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.

Code Information

Lot Numbers / Expiration Date 84126UN20 / 09JUL2021 03676UN20 / 25AUG2021 10597UN20 / 29AUG2021 26275UN20 / 20OCT2021 77748UN20 / 08DEC2021 65958UN20 / 08DEC2021 81824UN21 / 16FEB2022

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  • Z-0489-2026 Class II — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalo (September 18, 2025)
  • Z-1655-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1653-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1656-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04 (March 18, 2025)
  • Z-1652-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1654-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-2681-2024 Class II — Alinity hq Analyzer, REF: 09P68-01 (June 14, 2024)
  • Z-1476-2024 Class II — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. (February 21, 2024)
  • F-0328-2024 Class II — Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil (October 31, 2023)

FDA data resources