Radiometer Medical ApS: Device Recall
Recall #Z-2426-2024 · 05/31/2024
Recall Details
- Recall Number
- Z-2426-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Radiometer Medical ApS
- Status
- Ongoing
- Date Initiated
- 05/31/2024
- Location
- Bronshoj, Denmark
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,127 analyzers
Reason for Recall
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
Product Description
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, 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 " In vitro testing of pleura samples for the pH parameter.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland.
Other Recalls by Radiometer Medical ApS
- Class II: Risk 03/21/2025