Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because an excess amount of surfactant was unintentionally added during manufacturing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates a violation or deviation from labeling or manufacturing requirements that is not likely to cause adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides (Reagent), reference/catalog numbers 192 6740 and 809 7990. The recall involves specific lots identified by generation and coating codes with expiration dates in October and November 2013.
The recall was initiated after the manufacturer determined during interval testing that an excess amount of surfactant was unintentionally added to the slides during the manufacturing process. These products are used for in vitro diagnostic testing to measure C-reactive protein concentration in serum and plasma.
The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico) and various international markets. The total quantity involved is 4,257 units domestically and 923 units foreign. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/
- 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 (7)
- GEN 3773
- Coating 0766
- Lot XXXX (exp. 11/01/2013)
- GEN 3784
- Coating 0767
- and GEN 3785
- Coating 0768
Distribution
Part of a larger recall action
This product is one of 2 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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