Recall Z-1760-2020 ยท CEM Electrode, Ion Specific, Potassium
Radiometer Medical ApS
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
| Date | Feb 3, 2020 |
| Status | Terminated |
| Reason | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment. |
| Root cause | Software design |
| Action | On 2/3/2020, the firm provided affected consignees with a "Urgent: Medical Device Recall" letter via Email, and hard copy letter via FedEx 2nd day. In addition to providing the recall notification, consignees were asked to take the following actions: Check if your institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL90. 1. If you use barcode types without a check digit, Radiometer recommends to either: - Enable the check digit on the barcode type currently used, or - Change type of barcode to one that includes a check |
| Quantity | 12,822 units |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, Aug 6, 2010 |