Recall Z-2426-2024 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
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 p
| Date | Jul 24, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 6/10/2024, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that an internal technical study was carried out based on reports from internal and external users regarding pH sensitivity and pH drift errors for calibrations and measured QC pH values out of range. The study concludes that there is a possibility of reporting biased out-of-specification pH results on blood samples. This may occur if the calibration solution's pH value decreases during the in-use period due to bacterial growth in the calibration solution bottles CAL1 and/or CAL2. Customers are in |
| Quantity | 27,127 analyzers |
| Distribution | 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, Alger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |