CLASS III Device recall · Reported 19 Sep 2018 · FDA Enforcement Report

Vitros Chemistry Products Cl- Slides, Product recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Cl- Slides, distributed nationwide in the US. The recall was initiated on 11 Jul 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesGEN 10 and above

Quantity recalled420105

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-3044-2018
FDA event ID: 80697
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class III
Status: Terminated
Recall initiated: 11 Jul 2018
FDA classified: 13 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

11 Jul 2018	Recall initiated by company
13 Sep 2018	Classified by FDA	+64 days
19 Sep 2018	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 slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.

Product as listed by the FDA

VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage:

Where it was distributed

Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GEN 10 and above

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.

Other products in this recall event

1 other product · FDA event 80697

This product is part of a recall event; the main page for the event is Vitros Chemistry Products Cl- Slides, Product recalled.

Reported	Class	Recall	Company	Reason	Where
19 Sep 2018	CLASS III	Vitros Chemistry Products Cl- Slides, Product recalled	Ortho-Clinical Diagnostics	Other	Nationwide

More recalls from Ortho-Clinical Diagnostics

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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
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