CLASS II ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report

Vitros Chemistry Products Performance Verifier recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Performance Verifier I, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled37429 units (US)/11,703 units (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2120-2025
FDA event ID: 97047
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jun 2025
FDA classified: 17 Jul 2025
Reported: 23 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

10 Jun 2025	Recall initiated by company
17 Jul 2025	Classified by FDA	+37 days
23 Jul 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Florida Georgia Illinois Maryland Michigan Missouri Mississippi New York Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97047

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025	CLASS II	Vitros Chemistry Products Performance Verifier II recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

More recalls from Ortho-Clinical Diagnostics

All 311

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

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