CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Vitros Chemistry Products VersaTips recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products VersaTips, distributed nationwide in the US. The recall was initiated on 10 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 10758750006786 Lot 1039734

Quantity recalled4125 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-0735-2022
FDA event ID: 89362
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Ongoing
Recall initiated: 10 Dec 2021
FDA classified: 8 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

10 Dec 2021	Recall initiated by company
8 Mar 2022	Classified by FDA	+88 days
16 Mar 2022	Published in enforcement report	+8 days

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

Reason for recall

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Where it was distributed

Domestic distribution nationwide. Foreign distribution to Canada.

Nationwide

Questions about this recall

Is Vitros Chemistry Products VersaTips recalled?

Yes. Ortho-Clinical Diagnostics recalled Vitros Chemistry Products VersaTips on 10 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0735-2022.

Why was it recalled?

Which lots are affected?

UDI 10758750006786 Lot 1039734

Where was it sold?

Domestic distribution nationwide. Foreign distribution to Canada.

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

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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
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