Recall Z-2304-2012 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Sendx Medical Inc
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL8
| Date | Aug 30, 2012 (initiated Jun 6, 2012) |
| Status | Terminated |
| Reason | The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition. |
| Root cause | Software design |
| Action | Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative. |
| Quantity | ABL80 FLEX is 1680, ABL80 CO-OX is 1759 |
| Distribution | Worldwide Distribution - US Nationwide including the state of OH. |
| FDA record | Open on fda.gov |