Abbott Point Of Care Inc.: Medical Device Recall in 2020 - (Recall #: Z-0761-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

i-STAT cTnI cartridge

Product Classification:

Class II

Date Initiated: October 16, 2019

Date Posted: January 8, 2020

Recall Number: Z-0761-2020

Event ID: 84166

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.

Status: Terminated

Product Quantity: 3,465,875

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated