Abbott Laboratories: Medical Device Recall in 2021 - (Recall #: Z-2184-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569

Product Classification:

Class II

Date Initiated: June 10, 2021

Date Posted: August 11, 2021

Recall Number: Z-2184-2021

Event ID: 88123

Reason for Recall:

There is a potential for 15% 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.

Status: Ongoing

Product Quantity: 4,727 units

Code Information:

Lot Numbers / Expiration Date 83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022

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.

Voluntary or Mandated:

Voluntary: Firm initiated