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.
What this means for you
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 Chemist
- 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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