Lower risk Medical device recall · FDA · Published June 10, 2021

Abbott Activated Alanine Aminotransferase Recall: Risk of Incorrect Patient Results

Abbott recalls specific Activated Alanine Aminotransferase test kits for potential incorrect patient results due to under-recovery in high sample concentrations. Affected lots may cause inaccurate bilirubin results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2187-2021Medical device Abbott ›

Lower-risk 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

Take action

Contact the company

Recalling firmAbbott Laboratories1915 Hurd Dr · Irving, TX 75038

✎ GovInfoNow plain-language explainer

Abbott is recalling certain Activated Alanine Aminotransferase test kits that could produce incorrect patient results for samples with high bilirubin levels or very high enzyme concentrations. This might lead to wrong medical decisions if not addressed. Read more at govinfonow.com/recall/62351-abbott-activated-alanine-aminotransferase-recall-risk-of-incorrect-patient-results.

Source Summary by GovInfoNow · govinfonow.com/recall/62351-abbott-activated-alanine-aminotransferase-recall-risk-of-incorrect-patient-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2187-2021

Cite this page

“Abbott Activated Alanine Aminotransferase Recall: Risk of Incorrect Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62351-abbott-activated-alanine-aminotransferase-recall-risk-of-incorrect-patient-results. Based on FDA recall #Z-2187-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2187-2021%22&limit=1).

The FDA announced on June 10, 2021, that Abbott Laboratories is recalling its Activated Alanine Aminotransferase test kits due to potential incorrect patient results. The hazard involves under-recovery for high sample values and shifts in results with high bilirubin concentrations.

How to tell if you have it

Brand: Abbott
Product: REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
UPC: 00380740161866
Lot Numbers / Expiration Dates: 84126UN20 / 09JUL2021, 03676UN20 / 25AUG2021, 10597UN20 / 29AUG2021, 26275UN20 / 20OCT2021, 77748UN20 / 08DEC2021, 65958UN20 / 08DEC2021, 81824UN21 / 16FEB2022
Units affected: 2,212

The hazard

According to the FDA, there is a potential for greater than 10% under-recovery on Activated Alanine Aminotransferase samples greater than 1,200 U/L. There is also a potential for a greater than 10% shift in patient results with samples containing bilirubin concentrations greater than 31 mg/dL. This could lead to incorrect patient results.

Context

GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Other recent recalls of similar products include Abbott Alinity hq Analyzer Software Issue (Sept. 18, 2025) and Abbott CELL-DYN Ruby: Expired Reagents Cause Incorrect Date Updates (March 18, 2025). Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (July 6, 2026), Abbott ID NOW Influenza A & B 2 Kit (Feb. 9, 2026), and Siemens Atellica CH A1c_E Test Recall (June 8, 2026).

How to tell if you have this one

Check the lot number on the kit, which includes codes like 84126UN20, 03676UN20, 10597UN20, 26275UN20, 77748UN20, 65958UN20, or 81824UN21. These kits were sold with specific expiration dates between July 2021 and February 2022.

Brand
Abbott
Product
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots	Quantity
Z-2184-2021	REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569; Lot Numbers / Expiration Date 83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022	4,727 units
Z-2185-2021	REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859; Lot Numbers / Expiration Date 02954UN20 / 29AUG2021 37921UN20 / 01DEC2021 81823UN21 / 16FEB2022	1,603 units
Z-2186-2021	REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866; Lot Numbers / Expiration Date 15014UN20 20OCT2021 09153UN21 09MAR2022 *Not distributed within the US.	36 units
Z-2187-2021	REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866; Lot Numbers / Expiration Date 84126UN20 / 09JUL2021 03676UN20 / 25AUG2021 10597UN20 / 29AUG2021 26275UN20 / 20OCT2021 77748UN20 / 08DEC2021 65958UN20 / 08DEC2021 81824UN21 / 16FEB2022	2,212 units

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for lot numbers such as 84126UN20, 03676UN20, 10597UN20, 26275UN20, 77748UN20, 65958UN20, or 81824UN21 on the test kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jun 10, 2021Firm started the recall
Aug 2, 2021FDA classified it Class II
Aug 11, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which lots of the test kits are affected?

Affected lots include 84126UN20 (expiring 09JUL2021), 03676UN20 (25AUG2021), 10597UN20 (29AUG2021), 26275UN20 (20OCT2021), 77748UN20 (08DEC2021), 65958UN20 (08DEC2021), and 81824UN21 (16FEB2022).

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Link to this recall

<a href="https://govinfonow.com/recall/62351-abbott-activated-alanine-aminotransferase-recall-risk-of-incorrect-patient-results">Abbott Activated Alanine Aminotransferase Recall: Risk of Incorrect Patient Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2187-2021 (June 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2187-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.