OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgi
FDA device recall Z-0119-2008 · posted 2007-11-09 · Terminated
Recall details
- Recalling firm
- Opti Medical Systems Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JGS
- Quantity affected
- 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, Thai
- Date initiated
- 2007-07-18
- Date posted
- 2007-11-09
- Date terminated
- 2007-12-13
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (K052027) | Osmetech, Inc. | 2005-09-29 |