VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical D
FDA device recall Z-0913-05 · posted 2005-06-21 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Potential for positively biased results in QC and patient samples.
- Action taken
- Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLI
- Quantity affected
- Domestic - 1359; International - 840
- Distribution
- Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.
- Date initiated
- 2005-03-15
- Date posted
- 2005-06-21
- Date terminated
- 2006-02-10
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-18 |