CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
ReQuest Measles IgM Enzyme Linked Immunoabsorbant Assay, Rubeola IgM recalled
Quest International is recalling ReQuest Measles IgM Enzyme Linked Immunoabsorbant Assay, Rubeola IgM, distributed nationwide in the US. The recall was initiated on 17 Jul 2025 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-2552-2025
- FDA event ID
- 97419
- Recalling firm
- Quest International, Doral, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2025
- FDA classified
- 11 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jul 2025 | Recall initiated by company | |
| 11 Sep 2025 | Classified by FDA | +56 days |
| 17 Sep 2025 | 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
Measles IgM Test Kit lacks premarket approval or clearance.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
Where it was distributed
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Questions about this recall
Why was it recalled?
Measles IgM Test Kit lacks premarket approval or clearance.
Which lots are affected?
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Where was it sold?
US Nationwide distribution in the states of Utah, Texas, and Arizona.
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.
More recalls from Quest International
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay recalled | Quest International | Potency & Assay | UT, WA |
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