Z-0913-05

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label...

Name: Z-0913-05 VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label...
Creator: Ortho-Clinical Diagnostics
Published: 2005-03-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-03-15 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK on 2005-03-15. The reason FDA records is "Potential for positively biased results in QC and patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0913-05
Status: Terminated
Initiated: 2005-03-15
Posted: 2005-06-21
Terminated: 2006-02-10
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: Potential for positively biased results in QC and patient samples.
FDA root cause: Other
Action: Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
Quantity in commerce: Domestic - 1359; International - 840
Distribution: Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.
Product codes and lots: Lot 710, Exp. 7/28/05

Product code KLI

K964721Class IIVitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators (Gem.c005)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-12-18

MDM coverage of this record lists here, newest first.

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)