Z-0912-2018Class II

VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

Name: Z-0912-2018 VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
Creator: Ortho-Clinical Diagnostics
Published: 2017-09-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-09-22 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic on 2017-09-22. FDA classified it as Class II and gives the reason as "This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control". 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-0912-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Posted: 2018-03-06
Terminated: 2020-08-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
Product code: DIF Drug Mixture Control Materials
Reason for recall: This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On September 18, 2017 a letter was sent to customers who received the BENZ reagent within the past 18 months of affected lots. The letter stated that customers may continue use of the product if QC results using VITROS DAT Performance Verifiers are within established ranges for each assay. If QC BENZ results are below established ranges, the customer should discontinue use of the product. The letter requests customers post the notification by each system that processes the VITROS BENZ Reagent. If the product was transferred outside of the facility, to notify those customers as well. Affected lots will be replaced in 6-8 weeks. Questions or concerns can be directed to 585-453-3452
Quantity in commerce: 323
Distribution: Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
Product codes and lots: Catalog# 6802328 Lot# J5617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0912-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0911-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0912-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0913-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0914-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0915-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06

Product code DIF

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)