CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Zeus Elisa Parvovirus B19 IgM Test System, Product Number SM9Z7701G recalled
Zeus Scientific is recalling Zeus Elisa Parvovirus B19 IgM Test System, Product Number SM9Z7701G, distributed in 7 states. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0603-2024
- FDA event ID
- 93514
- Recalling firm
- Zeus Scientific, Branchburg, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2023
- FDA classified
- 21 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Oct 2023 | Recall initiated by company | |
| 21 Dec 2023 | Classified by FDA | +51 days |
| 27 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Where it was distributed
US States: CA, MA, MI, NJ, NY, TN, UT.
CaliforniaMassachusettsMichiganNew JerseyNew YorkTennesseeUtah
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239
Where was it sold?
US States: CA, MA, MI, NJ, NY, TN, UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93514| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zeus Elisa Parvovirus B19 IgG Test System, Product Number SM9Z7701M recalled | Zeus Scientific | Other | 7 states |
More recalls from Zeus Scientific
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Zeus Elisa Parvovirus B19 IgG Test System, Product Number SM9Z7701M recalled | Zeus Scientific | Other | 7 states |
| Device | CLASS II | Zeus Elisa Parvovirus B19 IgM Test System recalled by Zeus Scientific | Zeus Scientific | Processing Deviation | Nationwide |
| Device | CLASS II | Dynex DSX recalled by Zeus Scientific | Zeus Scientific | Potency & Assay | Nationwide |
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