Abbott Point Of Care Inc.: Medical Device Recall in 2021 - (Recall #: Z-0880-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

Product Classification:

Class II

Date Initiated: December 22, 2020

Date Posted: January 27, 2021

Recall Number: Z-0880-2021

Event ID: 87073

Reason for Recall:

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

Status: Terminated

Product Quantity: 2,820,000 cartridges US and 2,273,453 catridges OUS

Code Information:

Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated