Recall Z-2468-2020 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
| Date | May 11, 2020 |
| Status | Terminated |
| Reason | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment. |
| Root cause | Under Investigation by firm |
| Action | The firm will send consignees Urgent Medical Device Recall Letter dated 5/11/2020 via email and FedEx 2nd day delivery with proof of delivery on 5/11/2020 informing them that Radiometer has become aware that the internal barcode reader, included in every ABL80 FLEX Series analyzers, may potentially misinterpret 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. The issue identified only relates to barcode types not using a check digit. A check digit enables the barcode reader to validate th |
| Quantity | 1981 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080370 | ABL 80 CO-OX SYSTEM Sendx Medical, Inc., Jul 31, 2008 |