Device recall: ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Class II FDA enforcement event 93514. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zeus Scientific, Inc. started this device recall on 31 Oct 2023. The firm address in the FDA record is in Branchburg, NJ. FDA put the recall in Class II. FDA event 93514 has 2 product records. The first FDA enforcement report date is 27 Dec 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US States: CA, MA, MI, NJ, NY, TN, UT.
Recalling firm
Zeus Scientific, Inc., Branchburg, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0602-2024 | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M | 296 kits | Class II | Ongoing | 27 Dec 2023 |
| Z-0603-2024 | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G | 293 kits | Class II | Ongoing | 27 Dec 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Aug 2019 | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of | Device | Class II | 1 |
| 22 Jul 2019 | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEU | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0602-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93514. https://recallregister.com/fda/ii/93514/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US States: CA, MA, MI, NJ, NY, TN, UT.
- What quantity of product is in FDA event 93514?
- The event has 2 product records. The first record gives this quantity:
296 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.