Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertifie
FDA device recall Z-0137-06 · posted 2005-11-15 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased.
- Action taken
- Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J foreign affiliates. Customers instructed to immediately discontinue using reflex processing to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.
- Root cause
- Other
- Status
- Terminated
- Product code
- KHO
- Quantity affected
- 3,507 Vitros ECi units distributed
- Distribution
- Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
- Date initiated
- 2005-09-29
- Date posted
- 2005-11-15
- Date terminated
- 2007-07-31
- 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 IMMUNODIAGNOSTIC SYSTEM (K962919) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-10-18 |