Reported Feb 26, 2020 · Terminated
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may…
Abbott Point Of Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
i-STAT G3+ cartridge (blue)List No. 03P78-50
- UDI (01) 00054749002283 - Product UsageThe i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood
- Lot codes and dates
- All lots are affected
- Amount recalled
- 4,448,525
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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