Radiometer America Inc: Medical Device Recall in 2017 - (Recall #: Z-0231-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 24, 2017

Date Posted: December 20, 2017

Recall Number: Z-0231-2018

Event ID: 78445

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.

Status: Terminated

Product Quantity: 1,749 analyzers

Code Information:

All serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated