CLASS III Device recall · Reported 6 May 2020 · FDA Enforcement Report

Vitros Immunodiagnostic Products TT4 Reagent Pack, Product recalled

Ortho Clinical Diagnostics is recalling Vitros Immunodiagnostic Products TT4 Reagent Pack, distributed nationwide in the US. The recall was initiated on 10 Mar 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI: 10758750005147; Lot Number: 2340

Quantity recalled3181

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-1834-2020
FDA event ID: 85298
Recalling firm: Ortho Clinical Diagnostics, Rochester, NY
Classification: Class III
Status: Terminated
Recall initiated: 10 Mar 2020
FDA classified: 30 Apr 2020
Reported: 6 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

10 Mar 2020	Recall initiated by company
30 Apr 2020	Classified by FDA	+51 days
6 May 2020	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

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Product as listed by the FDA

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Where it was distributed

US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.

Nationwide

Questions about this recall

Why was it recalled?

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Which lots are affected?

UDI: 10758750005147; Lot Number: 2340

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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