Opti Medical Systems Inc OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Brand
Opti Medical Systems Inc
Lot Codes / Batch Numbers
Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
Products Sold
Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
Opti Medical Systems Inc is recalling OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, due to Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026