FDAClass IIJanuary 31, 2024

DiaSorin LIAISON HSV-2 Type Specific IgG recall

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Why was DiaSorin LIAISON HSV-2 Type Specific IgG recalled?

DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.

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/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775

Product
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Recalling firm
Diasorin Inc.
Quantity
31992 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
January 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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