Recall Z-1314-06 ยท CGZ Electrode, Ion-Specific, Chloride
Radiometer America Inc
D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
| Date | Aug 1, 2006 (initiated Feb 1, 2005) |
| Status | Terminated |
| Reason | The CI membrane units generate too low values for status and sensitivity during calibration. |
| Root cause | Other |
| Action | The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot. |
| Quantity | 85/4 unit boxes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc., Feb 9, 1998 |