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.
FDA Recall Z-1083-2010 · Posted 2010-03-11
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Recalling FirmOPTI Medical Systems, Inc
Recall StatusTerminated
Product CodeCGZ
Date Initiated2009-04-20
Date Terminated2012-04-17
Product Quantity127 boxes of 25 cassettes each for a total of 3175 cassettes.
Reason for Recall
Outer box labeling shows an incorrect storage temperature range.
Firm Action
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).
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.
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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