Home / Recalls / Abbott Point Of Care Inc. / Z-0761-2020

Z-0761-2020 Class II Terminated

Recalled by Abbott Point Of Care Inc. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
January 8, 2020
Initiation Date
October 16, 2019
Termination Date
May 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,465,875

Product Description

i-STAT cTnI cartridge

Reason for Recall

i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

Distribution Pattern

US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY

Code Information

List Number: 06P23-25 UDI: (01)00054749001986

Other recalls by Abbott Point Of Care Inc.

  • Z-2584-2025 Class II — i-STAT EG7+ cartridge. List Number: 03P76-25. (August 21, 2025)
  • Z-2585-2025 Class II — i-STAT EG6+ cartridge. List Number: 03P77-25. (August 21, 2025)
  • Z-2583-2025 Class II — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940 (August 21, 2025)
  • Z-2582-2025 Class II — i-STAT CG4+ cartridge (white). List Number: 03P85-25. (August 21, 2025)
  • Z-0881-2021 Class II — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of (December 22, 2020)
  • Z-0880-2021 Class II — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sod (December 22, 2020)
  • Z-1262-2020 Class II — i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Pr (January 15, 2020)
  • Z-1263-2020 Class II — i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Produ (January 15, 2020)
  • Z-1265-2020 Class II — i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Produc (January 14, 2020)
  • Z-0615-2019 Class II — Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of (September 13, 2018)