Home / Recalls / Abbott Gmbh & Co. KG / Z-1728-2020

Z-1728-2020 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden, N/A

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
March 9, 2020
Termination Date
February 11, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,347 kits

Product Description

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

Reason for Recall

An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

Distribution Pattern

US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.

Code Information

List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.

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-2401-2020 Class II — Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. (May 12, 2020)
  • Z-2117-2020 Class II — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are (April 24, 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)