Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 81,382 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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical or low-risk hazard consistent with a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges used with some VITROS Chemistry Product Slides. The recall is being conducted due to slide dispense issues. The affected product includes VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack, catalog number 1513209, which are used to quantitatively measure phosphorus concentration in serum, plasma, and urine.
The recall involves 81,382 units, with 28,256 units distributed domestically in the United States and 53,126 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 VITROS 250/350/950/5,1 FS, 4600, or 5600 Integrated Chemistry Systems should stop using the affected Slide Dispense cartridges and contact Ortho-Clinical Diagnostics for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
- 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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