Z-0866-05

VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50...

Name: Z-0866-05 VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50...
Creator: Ortho-Clinical Diagnostics
Published: 2005-04-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-04-18 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical... on 2005-04-18. The reason FDA records is "Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0866-05
Status: Terminated
Initiated: 2005-04-18
Posted: 2005-06-04
Terminated: 2005-10-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
Product code: LEG Enzyme Immunoassay, Valproic Acid
Reason for recall: Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
FDA root cause: Other
Action: Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.
Quantity in commerce: 139 boxes
Distribution: 37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.
Product codes and lots: 01-5871, Exp. 31Jan06

Product code LEG

K042476Class IIVitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products Tdm PerfosOrtho-Clinical Diagnostics, Inc. / cleared 2004-12-01

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)