Zeus Scientific recalls Parvovirus B19 IgM Test System (UDI 00845533001755) due to increased false positives. This affects lab tests for Parvovirus B19 in blood samples.
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.
Zeus Scientific is recalling a Parvovirus B19 IgM Test System because it has been found to produce more false positive results. This could lead to incorrect diagnoses of Parvovirus B19 exposure, which is important for women of childbearing age.
The test system has been found to produce more false positive results than expected. This means it might incorrectly indicate Parvovirus B19 exposure when there is none, potentially leading to unnecessary medical concerns or treatments.
People using this test system for blood screening, especially women of childbearing age who may be at risk for Parvovirus B19 exposure. Laboratories and healthcare providers are most affected.
Check for the unique identifier (UDI) 00845533001755 on the test system packaging. This product was sold with lot number 19040014.
Look for the unique identifier (UDI) 00845533001755 on the test system packaging.
The FDA inspection found that the test system produces more false positive results than expected, which could lead to incorrect diagnoses of Parvovirus B19 exposure.
Check the unique identifier (UDI) 00845533001755 on the packaging. If it matches, contact Zeus Scientific for guidance.
The test system is safe to use but may produce false positives. It is recommended to check for the UDI and contact Zeus Scientific if you have the specific model.
We’ve drafted a message you can send Zeus Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3026-2020 — Zeus Scientific Zeus Scientific Hello, I own a Zeus Scientific that is covered by recall Z-3026-2020 from Zeus Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
