VITROS Chemistry CHE Slides (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch 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.
Products Sold
Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 s due to Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This dri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026