Recall Z-0190-2027 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.
| Date | Oct 15, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| Reason | In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings. |
| Root cause | No Marketing Application |
| Action | On 8/18/2026, correction notices were mailed or emailed to customers who were asked to take the actions listed in the correction notice. The firm updated intended use and instructions for use. In addition, the firm is developing an updated software version that will modify the analyzer configuration in accordance with the updated FDA clearances. Customers are asked to do the following: 1) Implement the requested changes to the setup of your analyzer(s) as stated in the correction letter. 2) Review the changes to the labeling for the analyzers as stated in the updated Instructions for Use. 3 |
| Quantity | 5395 |
| Distribution | US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |