Recall Z-0119-2008
Opti Medical Systems Inc · initiated July 18, 2007
Product
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Codes / lots: Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0119-2008
- Initiated
- July 18, 2007
- Posted by FDA
- November 9, 2007
- Terminated
- December 13, 2007
- Product code
- JGS – Electrode, Ion Specific, Sodium
- 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.
- Recalling firm
- Opti Medical Systems Inc, Roswell, GA