Home / Recalls / Abbott Ireland Diagnostics Division / Z-0667-2019

Z-0667-2019 Class II Terminated

Recalled by Abbott Ireland Diagnostics Division — Co. Longford

FDA device recall Z-0667-2019 was initiated by Abbott Ireland Diagnostics Division on November 21, 2018 and is designated Class II. Reason for recall: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it m… The recall status is terminated (terminated April 1, 2021). Affected quantity: 79 units.

Recall Details

Product Type
Devices
Report Date
January 2, 2019
Initiation Date
November 21, 2018
Termination Date
April 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
79 units

Product Description

Alinity i Estradiol Reagent Kit, List Number 07P5020

Reason for Recall

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

Distribution Pattern

AR, FL, GA, MD, OK, VA

Code Information

UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00

Other recalls by Abbott Ireland Diagnostics Division

  • Z-1353-2019 Class II — Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol (February 5, 2019)
  • Z-1354-2019 Class II — Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assa (February 5, 2019)
  • Z-0668-2019 Class II — Alinity i Progesterone Reagent Kit, List Number 08P3620 (November 21, 2018)
  • Z-0664-2019 Class II — Alinity i TSH Reagent Kit, List Number 07P4830 (November 21, 2018)
  • Z-0665-2019 Class II — Alinity i Free T4 Reagent Kit, List Number 07P7030 (November 21, 2018)
  • Z-0669-2019 Class II — Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 (November 21, 2018)
  • Z-2208-2019 Class II — Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin a (November 21, 2018)
  • Z-0666-2019 Class II — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 (November 21, 2018)
  • Z-0799-2019 Class II — ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platfo (October 12, 2018)
  • Z-0798-2019 Class II — ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platfor (October 12, 2018)

FDA data resources