Z-0471-2021Class III

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products...

Name: Z-0471-2021 VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products...
Creator: Ortho Clinical Diagnostics Inc
Published: 2020-10-16
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-10-16 / Open, Classified

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to... on 2020-10-16. FDA classified it as Class III and gives the reason as "Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0471-2021
Classification: Class III
Status: Open, Classified
Initiated: 2020-10-16
Posted: 2020-11-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics issued letter IMPORTANT PRODUCT CORRECTION NOTIFICATION (CL2020-243) on 16 October 2020 via FedEx/US Priority Mail or ORTHO Plus e-Communications for delivery on October 19, 2020, stating reason for recall, health risk and action to take: If their laboratory used VITROS Performance Verifier II Lot Q7692 to verify performance of VITROS ALKP Slides and stores an inventory of unopened vials in the refrigerator: Discard any remaining refrigerated inventory of unopened VITROS Performance Verifier II Lot Q7692. If their laboratory does not store inventory of VITROS Performance Verifier II Lot Q7692 in the refrigerator or does not use Lot Q7692 to verify performance of VITROS ALKP Slides: No Action Is Required. To verify performance of VITROS ALKP Slides, use frozen (never refrigerated) inventory of VITROS Performance Verifier II Lot Q7692 or switch to another lot of VITROS Performance Verifier II. Ortho will replace or credit your account as indicated on your Confirmation of Receipt form Retain this notification as verification of the revised instructions. OUS notified by email on 09/14/20 to global affiliates for distribution to distributors and customers.
Quantity in commerce: 10788 total: US 4680; OUS 6108
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0471-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0471-2021	Class III	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-18

Product code JJY

K904768Class IKodatrol I and II Control and Diluent SetEastman Kodak Company / cleared 1990-11-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)