VITROS Chemistry Products VersaTips recall
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Why was VITROS Chemistry Products VersaTips recalled?
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI 10758750006786 Lot 1039734
- Product
- VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 4125 units
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Recall date
- March 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)