OPTI Medical Systems, Inc OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
Brand
OPTI Medical Systems, Inc
Lot Codes / Batch Numbers
Lot numbers: 904801, 904803 and 915800.
Products Sold
Lot numbers: 904801, 904803 and 915800.
OPTI Medical Systems, Inc is recalling OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be use due to Outer box labeling shows an incorrect storage temperature range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Outer box labeling shows an incorrect storage temperature range.
Recommended Action
Per FDA guidance
OPTI Medical Systems, Inc. issued a "Medical Device Correction" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card. For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).
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