Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DGXN Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DGXN Slides because the Instructions for Use were revised to remove heparin plasma as a recommended specimen type.
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. The hazard involves a labeling/instruction error regarding specimen type rather than a direct physical defect or reported illness, fitting the criteria for moderate severity.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DGXN Slides, reference number 834 3386. The product is intended for in vitro diagnostic use only and is used to quantitatively measure digoxin concentration in serum and plasma using specific VITROS Chemistry Systems.
The recall was initiated because Ortho-Clinical Diagnostics revised the Instructions for Use (IFU) for these slides. The revision specifically removed heparin plasma as a recommended specimen type for the VITROS DGXN Slides.
The affected units are 13,338 sale units distributed nationwide in the United States. The affected lots are identified by coating codes 0204, 0205, and 0206. Users of these products should stop using the affected slides and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Sli
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 13,338
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)
- Lots from coating 0204
- 0205
Distribution
Distributed nationwide across the United States.
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