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

Vitros Chemistry Products CHE Slides recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products CHE Slides, 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 codesCatalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.

Quantity recalled27, 330 US/ 19,679,730 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-2122-2025
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: Other Medical Devices

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

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

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?

Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.

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

This product is part of a recall event; the main page for the event is Vitros Chemistry Products Performance Verifier recalled.

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

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