The Recall Desk
ModerateFDA (Devices)·Z-0301-2014·Announced 2013-11-27

Ortho-Clinical Diagnostics Recalls VITROS BUN/UREA Slides Due to Dispense Issues

Ortho-Clinical Diagnostics is recalling VITROS BUN/UREA Slides because of slide dispense issues. The recall affects units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text cites 'slide dispense issues' without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BUN/UREA Slides, packaged as 300 slides per pack with catalog number 8102204. The recall is due to slide dispense issues associated with the Slide Dispense cartridges used with these products.

The affected slides are used to quantitatively measure urea concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall covers multiple lots with expiry dates through March 22, 2015.

The recall includes 31,0947 units, comprising 139,602 units distributed domestically and 171,345 units distributed internationally. Distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and various countries in Europe, Asia, the Americas, and Australia.

The recalled product

Product
VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS a
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — In Vitro Diagnostics
Hazard

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 →

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