Reported Dec 20, 2017 · Terminated
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters…
Radiometer America 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: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
- Lot codes and dates
- All serial numbers
- Amount recalled
- 1,749 analyzers
Where it was sold
Why it was recalled
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
This product could cause temporary or reversible health problems — stop using it.
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