Recall Z-1083-2010
OPTI Medical Systems, Inc · initiated April 20, 2009
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.
Codes / lots: Lot numbers: 904801, 904803 and 915800.
Reason for recall
Outer box labeling shows an incorrect storage temperature range.
FDA-determined cause: Process control
Action taken
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).
Details
- Recall number
- Z-1083-2010
- Initiated
- April 20, 2009
- Posted by FDA
- March 11, 2010
- Terminated
- April 17, 2012
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Quantity
- 127 boxes of 25 cassettes each for a total of 3175 cassettes.
- Distribution
- Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.
- Recalling firm
- OPTI Medical Systems, Inc, Roswell, GA