Laboratory diagnostic tips recalled for potential dispensing errors
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a laboratory diagnostic device with a confirmed shape deformity causing potential volume reduction errors. The potential clinical impact—false positive or false negative results for bloodborne infectious disease assays—is significant. However, no actual illnesses or injuries are reported. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products VersaTips (Catalog No. 6801715). The recall involves 4,125 units (UDI 10758750006786, Lot 1039734) distributed domestically nationwide and to Canada.
The tips have a shape deformity that may reduce the volume of sample or reagent dispensed by approximately 16%. This defect could affect the accuracy of laboratory test results.
If the dispensing 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.
The recalled product
- Product
- VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 4,125
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 (1)
- UDI 10758750006786 Lot 1039734
Distribution
Distributed nationwide across the United States.
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