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Z-2401-2020 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden

FDA device recall Z-2401-2020 was initiated by Abbott Gmbh & Co. KG on May 12, 2020 and is designated Class II. Reason for recall: There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase. The recall status is terminated (terminated January 31, 2023). Affected quantity: 421 serial numbers.

Recall Details

Product Type: Devices
Report Date: June 24, 2020
Initiation Date: May 12, 2020
Termination Date: January 31, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 421 serial numbers

Product Description

Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

Reason for Recall

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

Distribution Pattern

U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.

Code Information

List Number: 03R67-01: All serial numbers

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