Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results
Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.
What this means for you
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 medical device recall with risk of diagnostic harm (false positive results) but no reported illnesses, injuries, or hospitalizations. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
Ventana Medical Systems, Inc., is recalling the Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, Reference 790-4506. The product is an in vitro diagnostic medical device used for immunohistochemistry testing. Approximately 22,839 kits have been distributed worldwide.
The recall was issued due to a potential for high background and off-target staining when using the monoclonal primary antibody, which can result in false positive test results. This staining issue may compromise the accuracy of diagnostic findings.
The affected product has been distributed worldwide, including throughout the United States and Puerto Rico, and to numerous countries including Austria, Belgium, France, Germany, Italy, Japan, Australia, Canada, China, India, South Korea, and others.
The recalled product
- Product
- Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
- Manufacturer
- Ventana Medical Systems, Inc.
- Hazard
- false-positive-results
- off-target-staining
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 (12)
- UDI: 04015630972579/J04613
- J11853
- J17541
- J25047
- J30286
- K00982
- K06239
- K09880
- K14266
- K19784
- K26461
- and M00669
Distribution
Distributed nationwide across the United States.
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