Z-2122-2025Class II

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides)

Name: Z-2122-2025 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides)
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2025-06-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-06-10 / Open, Classified / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides) on 2025-06-10. FDA classified it as Class II and gives the reason as "Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2122-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-10
Posted: 2025-07-17
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Product code: DIH Colorimetry, Cholinesterase
Reason for recall: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Quantity in commerce: 27, 330 US/ 19,679,730 OUS
Distribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
Product codes and lots: Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2122-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2120-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17
Z-2121-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17
Z-2122-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17
Z-2123-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17

Product code DIH

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)