Ortho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry ALB Slides due to slide dispense issues. The recall affects 16,583 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a mechanical 'slide dispense issue' with no reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ALB Slides, 90 slides/pack (catalog number 1988211), due to slide dispense issues. These slides are used to quantitatively measure albumin (ALB) concentration in serum and plasma using specific VITROS Chemistry Systems.
The recall involves 16,583 units, with 3,073 distributed domestically and 13,510 distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was worldwide, including the United States (nationwide, including Puerto Rico) and various international markets such as Australia, Brazil, Canada, and several European and Asian countries.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- 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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