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U.S. Department of Health and Human Services

Class 2 Device Recall Zeus ELISA Parvovirus B19 Test System

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 Class 2 Device Recall Zeus ELISA Parvovirus B19 Test Systemsee related information
Date Initiated by FirmAugust 12, 2019
Create DateSeptember 29, 2020
Recall Status1 Terminated 3 on May 20, 2022
Recall NumberZ-3026-2020
Recall Event ID 86364
Product Classification Assay,enzyme linked immunosorbent,parvovirus b19 igm - Product Code MYM
ProductZEUS 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.
Code Information Lot 19040014
FEI Number 2242436
Recalling Firm/
Manufacturer		 Zeus Scientific, Inc.
199 Evans Way
Branchburg NJ 08876-4600
For Additional Information ContactChris Howard
908-526-3744
Manufacturer 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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionPending. The firm has not initiated customer notification for this issue.
Quantity in Commerce74
DistributionWorldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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