Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.
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. The source text identifies a functional defect (slide dispense issues) but does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dHDL Slides packaged as 300 slides per pack (catalog number 6801895). 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 HDL cholesterol concentration in serum and plasma on 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.
A total of 100,393 units were distributed, including 36,873 units domestically and 63,520 units internationally. Distribution was worldwide, including the United States (nationwide), Puerto Rico, and various international locations. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the return or replacement of the affected products.
The recalled product
- Product
- VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
- 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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