Z-0765-06

VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on...

Name: Z-0765-06 VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on...
Creator: Ortho-Clinical Diagnostics
Published: 2006-03-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2006-03-28 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which... on 2006-03-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0765-06
Status: Terminated
Initiated: 2006-03-28
Posted: 2006-04-20
Terminated: 2007-12-14
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 2000
Distribution: Medical facilities nationwide and 1 foreign affiliate in Canada.
Product codes and lots: Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)

Product code CDP

K964310Class IIVitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (Gem.c010)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-11-27

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)