Z-0299-04

Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on...

Name: Z-0299-04 Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on...
Creator: Ortho-Clinical Diagnostics
Published: 2003-12-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2003-12-03 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK on 2003-12-03. The reason FDA records is "Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0299-04
Status: Terminated
Initiated: 2003-12-03
Posted: 2004-01-06
Terminated: 2004-02-20
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
Product code: DHX System, Test, Carcinoembryonic Antigen
Reason for recall: Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.
Quantity in commerce: 524 reagent packs
Distribution: 154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
Product codes and lots: Lot #750, Exp. 14 January 2004

Product code DHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)