Ortho-Clinical Diagnostics 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for due to Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immuno. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026