Recall Z-3026-2020— Zeus Scientific, Inc.
Class II · Terminated
Class II FDA medical device recall by Zeus Scientific, Inc., initiated 2019-08-12, terminated 2022-05-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Zeus Scientific, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-12
- Terminated
- 2022-05-20
- Firm location
- Branchburg, NJ, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.