Z-2185-2021 Class II Ongoing
FDA device recall Z-2185-2021 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: 1,603 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
- 1,603 units
Product Description
Reason for Recall
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.