Recall Z-0119-2008 ยท JGS Electrode, Ion Specific, Sodium
Opti Medical Systems Inc
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
| Date | Nov 9, 2007 (initiated Jul 18, 2007) |
| Status | Terminated |
| Reason | Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested. |
| Quantity | 289 boxes of 25 cassettes |
| Distribution | Worldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 Osmetech, Inc., Sep 29, 2005 |