Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in
FDA device recall Z-0558-03 · posted 2003-02-21 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Label printing irregularities on cartons and/or bottles.
- Action taken
- Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 284 cartons/2 bottles per carton
- Distribution
- Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
- Date initiated
- 2003-01-10
- Date posted
- 2003-02-21
- Date terminated
- 2003-06-03
- 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 PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |