—#45148

Product

VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.

FDA product code: CDP — Radioimmunoassay, Total Triiodothyronine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K964310
Affected lot / code info: Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14626

Distribution

Distribution pattern: Medical facilities nationwide and 1 foreign affiliate in Canada.

Timeline

Recall initiated: 2006-03-28
Posted by FDA: 2006-04-20
Terminated: 2007-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.