Z-0984-2012

VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY...

Name: Z-0984-2012 VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY...
Creator: Ortho-Clinical Diagnostics
Published: 2011-05-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2011-05-10 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK... on 2011-05-10. The reason FDA records is "Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue". 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-0984-2012
Status: Terminated
Initiated: 2011-05-10
Posted: 2012-02-08
Terminated: 2016-02-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Product code: LEG Enzyme Immunoassay, Valproic Acid
Reason for recall: Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: All domestic end-user consignees were initially sent "Important Product Correction Notification" recall communications (dated 5/10/11) by Federal Express overnight mail on 5/10/11. The letters informed users of the issue, and advised them to discontinue using their VITROS VALP reagent until adjusted calibrator values are provided for GEN 14 of VITROS VALP Reagent. The adjusted calibrator values for VITROS VALP Reagent were sent to customers via Assay Data Disk (ADD) Data Release Version (DRV) 5632. Customers were to refer to the Technical Support Communication for details. Users were to confirm receipt of the notice by completing and returning the Fax Reply Form - Confirmation; confirm that all customers or distributors were informed of the issue and instructed to discontinue use of affected product; and lastly confirm that all customers or distributors were sent adjusted calibrator values.
Quantity in commerce: Approximately 5800 units worldwide (domestic - 4549, foreign - 1287)
Distribution: Worldwide Distribution -- US, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12).

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)