Z-0848-2019Class II

VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710

Name: Z-0848-2019 VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710
Creator: Ortho-Clinical Diagnostics
Published: 2018-12-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-12-11 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS... on 2018-12-11. FDA classified it as Class II and gives the reason as "Negative bias results when using VITROS VALP Reagent, GEN 25". 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-0848-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-11
Posted: 2019-02-19
Terminated: 2020-09-16
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Product code: LEG Enzyme Immunoassay, Valproic Acid
Reason for recall: Negative bias results when using VITROS VALP Reagent, GEN 25.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Ortho Clinical Diagnostics, issued on 11 December 2018, a "URGENT PRODUCT CORRECTION NOTIFICATION" customer letter (Ref. CL2018-267) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who were shipped VITROS Chemistry Products VALP GEN 25. Foreign affiliates were informed by email on 11 December 2018 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. The customers were notified of the issue and instructed to cease use of VALP GEN 25. If you have any GEN 25 (Lot 25-6393) remaining in your inventory, Ortho will provide replacement or credit your account. " Discontinue using Gen 25 (Lot 25-6393), discard any remaining inventory, and switch to GEN 26 or above. " If you do NOT have GEN 26 or above at this time, consider the following alternate options: o Use an alternate valproic acid method until your replacement order arrives. o Consult with your medical director to determine if the bias observed when using GEN 25 is acceptable for continued use, and if so, continue to use until your replacement arrive. In accordance with regulatory requirements, complete and return the Confirmation of Receipt - Response form no later than December 19, 2018 via Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS [email protected]. " Post this notification by your VITROS System or with your user documentation. " Forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311..
Quantity in commerce: 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
Distribution: Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
Product codes and lots: Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0848-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-19

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)