Agency classClass IIOur severity:High FDA (Devices)·Z-0305-2014·Announced 2013-11-27

Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues

Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall. While no specific injuries or illnesses are reported in the source text, the defect involves a functional failure (slide dispense issues) in a medical device used for diagnostic testing, which fits the criteria for a High severity rating where risk of harm exists but injury has not yet been reported.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CK Slides, which are used to quantitatively measure creatine kinase (CK) activity in serum and plasma. The recall is due to slide dispense issues with the Slide Dispense cartridges used with these products.

The affected products are packaged as 300 slides per pack (catalog number 8479396) and 90 slides per pack (catalog number 8478034). A total of 86,503 units are affected, with 30,378 units distributed domestically in the United States and 56,125 units distributed internationally. The recall covers multiple lots with expiry dates through March 22, 2015.

Distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and various international locations such as Australia, Brazil, Canada, and several European and Asian countries. The FDA has classified this as a Class II recall. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the return or replacement of these products.

The recalled product

Product: VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: functional-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Multiple lots affected
with expiry dates through 22-Mar-2015

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 37 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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