CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

Vitros Chemistry Products Trig Slides recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Trig Slides, distributed nationwide in the US. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 0704-3318-4774 (expiry date 01 Dec 2015)

Quantity recalledUSA: 380 units, Foreign: 155 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-0848-2015
FDA event ID: 69791
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2014
FDA classified: 22 Dec 2014
Reported: 31 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

6 Nov 2014	Recall initiated by company
22 Dec 2014	Classified by FDA	+46 days
31 Dec 2014	Published in enforcement report	+9 days

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

Reason for recall

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Product as listed by the FDA

VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Where it was distributed

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Which lots are affected?

Lot 0704-3318-4774 (expiry date 01 Dec 2015)

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.

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