Z-0231-2018 Class II Terminated
FDA device recall Z-0231-2018 was initiated by Radiometer America Inc on October 24, 2017 and is designated Class II. Reason for recall: 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 analyze… The recall status is terminated (terminated October 10, 2023). Affected quantity: 1,749 analyzers.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- October 24, 2017
- Termination Date
- October 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,749 analyzers
Product Description
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
Reason for Recall
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.
Distribution Pattern
USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.
Code Information
All serial numbers