Ortho-Clinical Diagnostics Recalls VITROS Chemistry CREA Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides due to slide dispense issues. The recall affects 364,752 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 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CREA Slides, catalog number 6802584, packaged as 300 slides per pack. These slides are used to quantitatively measure creatinine concentration in serum, plasma, and urine using specific VITROS Chemistry Systems. The recall is being conducted due to slide dispense issues with the Slide Dispense cartridges used with these products.
The recall involves 364,752 units, with 148,285 units distributed domestically in the United States and 216,467 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 international locations such as Australia, Brazil, Canada, and several European and Asian countries.
Healthcare facilities and laboratories using these products should stop using the affected VITROS Chemistry CREA Slides and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
- Manufacturer
- Ortho-Clinical 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
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.
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