REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Summary
The FDA issued a Class II for REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, by Abbott Laboratories. Reason: 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 pote.
Details
Source
Device Recall
External ID
Z-2185-2021
Action Date
2021-08-11
Status
Ongoing
Category
device
Product Description
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Lot/Code Info: Lot Numbers / Expiration Date 02954UN20 / 29AUG2021 37921UN20 / 01DEC2021 81823UN21 / 16FEB2022
Quantity Affected: 1,603 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-10
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2185-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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