Zeus ELISA Parvovirus B19 IgM Test System Recalled for False Positives
Zeus Scientific is recalling 74 units of the ZEUS ELISA Parvovirus B19 IgM Test System due to false positive results identified during an FDA inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device with a risk of harm (false positives) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zeus Scientific, Inc. is recalling 74 units of the ZEUS ELISA Parvovirus B19 IgM Test System (Lot 19040014). The recall was initiated after an FDA inspection identified that the test system produced increased false positive results. The product is intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum, including in women of childbearing age where there is a suspicion of exposure.
The affected product was distributed worldwide, including nationwide in the United States (specifically in CA, CT, IN, NJ, and TX) and in Canada. The firm assigned a new Correction Factor and a new lot number to the remainder of the affected lot and distributed this reworked product to customers.
Users of the affected test system should stop using the product and contact Zeus Scientific, Inc. for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- 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.
- Manufacturer
- Zeus Scientific, Inc.
- Hazard
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 19040014
Distribution
Related recalls
Same manufacturer · Zeus Scientific, Inc.
See all →- ModerateZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
FDA (Devices) · 2023-12-27
- ModerateZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
FDA (Devices) · 2023-12-27
- HighZeus Scientific Recalls Dynex DSX Software for False Negative ELISA Results
FDA (Devices) · 2019-09-18
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11