FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
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 diagnostic test that may produce false positive or equivocal results, creating risk of harm through unnecessary medical intervention or patient distress. No patient illnesses or injuries have been reported. This meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' warranting a High (3) severity rating.
Plain-English summary
DiaSorin Inc. is recalling specific lots of the LIAISON HSV-2 Type Specific IgG assay test kit. The affected lot numbers are 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, and 136775. These products have been distributed nationwide in the United States and in Canada.
The recall was issued because affected lots may produce increased numbers of equivocal and/or false positive results. False positive results in HSV-2 antibody testing could lead to unnecessary medical treatment, preventive measures, or patient distress based on inaccurate diagnosis.
Patients who received testing using affected lots should speak with their healthcare provider about their results and whether retesting may be appropriate. Healthcare providers who have used these test kits should review results from the affected lots.
DiaSorin has initiated the recall of these products. Customers should not use the affected lot numbers and should contact the manufacturer for return or replacement information.
The recalled product
- Product
- DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- Manufacturer
- Diasorin Inc.
- Affected units
- 31,992
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 (15)
- UDI/DI 08056771600101
- Lot Numbers: 136344
- 136344A
- 136344B
- 136344C
- 136520
- 136520A
- 136520B
- 136520C
- 136604
- 136703
- 136703A
- 136703B
- 136703C
- 136775
Distribution
Distributed nationwide across the United States.
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