OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement
FDA device recall Z-1083-2010 · posted 2010-03-11 · Terminated
Recall details
- Recalling firm
- OPTI Medical Systems, Inc
- Reason for recall
- Outer box labeling shows an incorrect storage temperature range.
- 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).
- Root cause
- Process control
- Status
- Terminated
- Product code
- CGZ
- Quantity affected
- 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.
- Date initiated
- 2009-04-20
- Date posted
- 2010-03-11
- Date terminated
- 2012-04-17
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (K052027) | Osmetech, Inc. | 2005-09-29 |