The Recall Desk
ModerateFDA (Devices)·Z-0302-2014·Announced 2013-11-27

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Ca Slides packaged as 300 slides per pack, catalog number 1450261. These slides are used to quantitatively measure calcium concentration in serum, plasma, and urine on specific VITROS Chemistry Systems. The recall is due to slide dispense issues associated with the Slide Dispense cartridges used with the product.

The recall affects 231,112 units, with 133,173 units distributed domestically in the United States and 97,939 units distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and various countries in the Americas, Europe, and Asia.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the provided text.

The recalled product

Product
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

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 →