VITROS recallZ-2122-2025 · Ortho-Clinical Diagnostics, Inc. · initiated Jun 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2122-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 10, 2025
- Posted by the FDA
- Jul 17, 2025
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 27, 330 US/ 19,679,730 OUS
- Product code
- DIH
- 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 description
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Code information (models, lots, serial numbers)
Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 1914605Ortho-Clinical Diagnostics, Inc. · Colorimetry, cholinesterase1 recall0 reports
- VITROS 8004707Ortho-Clinical Diagnostics, Inc. · Colorimetry, cholinesterase1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97047).
- Z-2120-2025 · Open, ClassifiedBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Descrip…
- Z-2121-2025 · Open, ClassifiedBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITRO…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page