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.
Reported: February 26, 2020 Initiated: January 14, 2020 #Z-1265-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 4,448,525
- Distribution
- US Nationwide distribution.
- Location
- Princeton, NJ
Frequently Asked Questions
What product 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.. Recalled by Abbott Point Of Care Inc.. Units affected: 4,448,525.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1265-2020.
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