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.
This recall has been terminated (originally issued August 12, 2019).
- Company
- Zeus Scientific, Inc.
- Recall Initiated
- August 12, 2019
- Terminated
- May 20, 2022
- Recall Number
- Z-3026-2020
- Quantity
- 74
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.
Lot / Code Info
Lot 19040014
Root Cause
Unknown/Undetermined by firm
Action Taken
Pending. The firm has not initiated customer notification for this issue.
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