VITROS Chemistry Products PHYT recall
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT…
Why was VITROS Chemistry Products PHYT recalled?
Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 2613-0150-4913, exp. 15-Nov-2014
- Product
- VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Domestic: 339 sales units; Foreign: 10 sales units
- Distribution
- Distributed USA (nationwide) and in Singapore.
- Recall date
- October 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)