VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS I
FDA device recall Z-0765-06 · posted 2006-04-20 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.
- Action taken
- Ortho-Clinical Diagnostics sent "Urgent Product Correction/Recall Notification" letters, dated 3/28/06, to the customers via overnight mail. Ortho-Clinical Diagnostics issued a nationwide press release on 3/31/06. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians. Ortho-Clinical Diagnostics has advised laboratories, using this reagent, to contact the patient's physician if there are any concerns regarding previous test results. Customers with questions may contact the company at 1-800-421-3311. Additionally, Ortho-Clinical Diagnostics notified all end users of the VITROS ECi/ECiQ Immunodiagnostic System in the US and globally.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDP
- Quantity affected
- 2000
- Distribution
- Medical facilities nationwide and 1 foreign affiliate in Canada.
- Date initiated
- 2006-03-28
- Date posted
- 2006-04-20
- Date terminated
- 2007-12-14
- Location
- Rochester, NY
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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 |