Abbott Point Of Care Inc. recalls i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may b…

Recall date

January 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1265-2020

FDA classification

Class II

Brand / firm

Abbott Point Of Care Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.