CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report

Vitros 250 Chemistry System, Product recalled

Ortho-Clinical Diagnostics is recalling Vitros 250 Chemistry System, distributed nationwide in the US. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled5020 units

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-1933-2019
FDA event ID: 82784
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 8 Apr 2019
FDA classified: 3 Jul 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Apr 2019	Recall initiated by company
3 Jul 2019	Classified by FDA	+86 days
10 Jul 2019	Published in enforcement report	+7 days

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

Reason for recall

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Product as listed by the FDA

VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Which lots are affected?

All lots

Where was it sold?

US Nationwide Distribution

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 82784

This product is part of a recall event; the main page for the event is Vitros 350 Chemistry System, Product recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019	CLASS II	Vitros 350 Chemistry System, Product recalled	Ortho-Clinical Diagnostics	Other	Nationwide
10 Jul 2019	CLASS II	Vitros 250 Chemistry System Refurbished, Product recalled	Ortho-Clinical Diagnostics	Other	Nationwide
10 Jul 2019	CLASS II	Vitros 250AT Chemistry System, Product recalled	Ortho-Clinical Diagnostics	Other	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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