OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
FDA Recall Z-0119-2008 · Posted 2007-11-09
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Recalling FirmOpti Medical Systems Inc
Recall StatusTerminated
Product CodeJGS
Date Initiated2007-07-18
Date Terminated2007-12-13
Product Quantity289 boxes of 25 cassettes
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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