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
FDA Recall Z-0231-2018 · Posted None
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2017-10-24
Date Terminated2023-10-10
Product Quantity1,749 analyzers
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.
Firm Action
Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.
Root Cause
Software in the Use Environment
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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