VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
FDA device recall Z-0173-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
- Action taken
- Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LEH
- Quantity affected
- 784 boxes x 6 packs x 50 tests
- Distribution
- Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, I
- Date initiated
- 2005-10-12
- Date posted
- 2005-11-18
- Date terminated
- 2008-09-22
- 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 CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386) | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |