Z-0558-03

Vitros Immunodiagnostic Products * UNIVERSAL WASH REAGENT * for in vitro diagnostic use only. The product...

Name: Z-0558-03 Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product...
Creator: Ortho-Clinical Diagnostics
Published: 2003-01-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2003-01-10 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters... on 2003-01-10. The reason FDA records is "Label printing irregularities on cartons and/or bottles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0558-03
Status: Terminated
Initiated: 2003-01-10
Posted: 2003-02-21
Terminated: 2003-06-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
Reason for recall: Label printing irregularities on cartons and/or bottles.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.
Quantity in commerce: 284 cartons/2 bottles per carton
Distribution: Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
Product codes and lots: Lot 5003, Exp. 12 September 2003

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

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)