Z-0807-2018Class III

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on...

Name: Z-0807-2018 VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on...
Creator: Ortho Clinical Diagnostics Inc
Published: 2017-07-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-07-10 / Terminated

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems... on 2017-07-10. FDA classified it as Class III and gives the reason as "VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0807-2018
Classification: Class III
Status: Terminated
Initiated: 2017-07-10
Posted: 2018-03-01
Terminated: 2020-08-06
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
FDA root cause: Unknown/Undetermined by firm
Action: On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.
Quantity in commerce: 10,021 units
Distribution: Worldwide
Product codes and lots: Lot K4852, Expiration 22 Feb 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0807-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code JJY

K042006Class IVitros Chemistry Products Dhdl Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products PerformaceOrtho-Clinical Diagnostics, Inc. / cleared 2004-10-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)