VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, N
FDA device recall Z-1460-05 · posted 2005-09-01 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
- Action taken
- Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCD
- Quantity affected
- 443 boxes
- Distribution
- The product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
- Date initiated
- 2005-07-19
- Date posted
- 2005-09-01
- Date terminated
- 2006-03-13
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479) | Ortho-Clinical Diagnostics, Inc. | 2005-01-06 |