medical Class II Updated 2020-02-26

Abbott Point Of Care Inc. recalls i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 000

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots are affected
View official government recall

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