Recall Z-1083-2010 ยท CGZ Electrode, Ion-Specific, Chloride
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.
| Date | Mar 11, 2010 (initiated Apr 20, 2009) |
| Status | Terminated |
| Reason | Outer box labeling shows an incorrect storage temperature range. |
| Root cause | Process control |
| 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). |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 Osmetech, Inc., Sep 29, 2005 |