Ortho-Clinical recalls VITROS Performance Verifier I models with potential inaccurate QC results due to quality control drift when used with specific enzyme slides. Affected lots may cause delayed patient results or erroneous test results.
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).
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling VITROS Performance Verifier I models that may produce inaccurate quality control results when used with certain enzyme slides. This could lead to delayed patient results or incorrect test outcomes if the device is used after the recommended reconstitution period. Read more at govinfonow.com/recall/52108-ortho-clinical-vitros-performance-verifier-i-inaccurate-qc-results-risk.
“Ortho-Clinical VITROS Performance Verifier I: Inaccurate QC Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52108-ortho-clinical-vitros-performance-verifier-i-inaccurate-qc-results-risk. Based on FDA recall #Z-2120-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2120-2025%22&limit=1).
The FDA announced on June 10, 2025, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier I due to quality control drift that may lead to inaccurate results. The agency issued recall number Z-2120-2025 for the voluntary Class II recall.
How to tell if you have it
Brand: Ortho-Clinical
Product Name: VITROS Chemistry Products Performance Verifier I
Model/Catalog Number: 806 7324
Lot Codes: V1665, B2245, Y2110, E2828
The hazard
Quality control drift occurs when certain lots of Performance Verifiers are used with certain lots of cholinesterase enzyme slides 2-7 days after reconstitution. This may lead to inaccurate QC results, potentially resulting in delayed patient results or erroneous patient results due to the need for repeat testing.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has issued 53 other recalls since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include Diagnostica Stago STA Staclot Protein S Recall (July 29, 2026), Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), and Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check for model number 806 7324 on the VITROS Performance Verifier I. Affected lots include V1665 (exp. 8/14/2025), B2245 (exp. 3/25/2026), Y2110 (exp. 3/25/2026), and E2828 (exp. 2/3/2027).
Brand
Ortho-Clinical
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-2120-2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: 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 Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component; Lot Code: Product Code: 806 7324 (UDI: 10758750004317) Lots currently within expiry: V1665 - Exp.8/14/2025 B2245 - Exp 3/25/2026 Y2110 - Exp. 3/25/2026 E2828 - Exp. 2/3/2027
37429 units (US)/11,703 units (OUS)
Z-2121-2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: 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 Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component; Lot Code: Product Code: 823 1474 (UDI: 10758750004577) Lots currently within expiry: W1667- Exp. 8/14/2025 X1901 - Exp. 11/20/2025 A2114 - Exp. 3/25/2026 D2338 - Exp. 6/3/2026 F2830 - Exp. 2/3/2027
36005 Units (US)/22,302 units OUS
Z-2122-2025
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.
Look for the lot code on the VITROS Performance Verifier I, which may be V1665, B2245, Y2110, or E2828.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Mississippi, Missouri, New York, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2120-2025 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2120-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.