Recall Z-0705-2007 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
| Date | Apr 6, 2007 (initiated Jan 16, 2007) |
| Status | Terminated |
| Reason | In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode. |
| Root cause | Other |
| Action | Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and com |
| Quantity | 64 in U.S. & 1,281 to foreign accounts |
| Distribution | Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX Radiometer Medical Aps, May 10, 2005 |