medical Class II Updated 2020-10-07

Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, UDI 0084553300175

Recalled Product

ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.


Hazard / Issue

FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 19040014
View official government recall

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