Home / Recalls / Abbott Gmbh & Co. KG / Z-2401-2020

Z-2401-2020 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden

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

Other recalls by Abbott Gmbh & Co. KG

  • Z-2701-2020 Class II — Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series sof (June 19, 2020)
  • Z-2117-2020 Class II — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are (April 24, 2020)
  • Z-1728-2020 Class II — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. (March 9, 2020)
  • Z-1580-2020 Class II — LN 3R70-01; software version 2.6.2 and earlier. The software is used with the A (January 24, 2020)
  • Z-0574-2020 Class II — ARCHITECT HAVAB-G Calibrator, REF 6L27-01 (November 7, 2019)
  • Z-0575-2020 Class II — Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostic (October 23, 2019)
  • Z-0544-2020 Class II — Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0543-2020 Class II — Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0545-2020 Class II — Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-2363-2019 Class II — Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: (June 10, 2019)