Z-1373-2024Class II

VITROS Performance Verifier II

Name: Z-1373-2024 VITROS Performance Verifier II
Creator: Ortho-Clinical Diagnostics
Published: 2024-02-27
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-02-27 / Open, Classified

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Performance Verifier II on 2024-02-27. FDA classified it as Class II and gives the reason as "The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1373-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-27
Posted: 2024-03-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Performance Verifier II
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
FDA root cause: Under Investigation by firm
Action: Consignees were sent an URGENT PRODUCT CORRECTION NOTIFICATION dated 2/27/24 informing them that for product Lot Q1174, diluent Lot M9815 was found in some sales units instead of the expected diluent Lot Q1175, and for product Lot R1176, diluent Lot P9967 was found in some sales units instead of the expected diluent Lot R1177. Consignees were asked to inspect their inventory to see if any mismatched product from affected lots was present and to discard any affected units. The provided Confirmation of Receipt form is to be returned by 3/8/24. Results received using affected devices are to be reviewed for any unexpected QC shift. The recall notification is to be forwarded if any devices were further distributed and the notification maintained in the User Documentation. Customers with any questions can call Global Services at 1-800-421-3311.
Quantity in commerce: 11,224 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1373-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1372-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1373-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)