CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay recalled
Quest International is recalling ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay, distributed in Utah, Washington. The recall was initiated on 1 Oct 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-0534-2026
- FDA event ID
- 97763
- Recalling firm
- Quest International, Doral, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2025
- FDA classified
- 17 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Oct 2025 | Recall initiated by company | |
| 17 Nov 2025 | Classified by FDA | +47 days |
| 26 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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 IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Where it was distributed
All products were distributed in the United States. (Utah, Washington).
Questions about this recall
Is ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay recalled?
Yes. Quest International recalled ReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay on 1 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0534-2026.
Why was it recalled?
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Which lots are affected?
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Where was it sold?
All products were distributed in the United States. (Utah, Washington).
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 21 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 IgM Enzyme Linked Immunoabsorbant Assay, Rubeola IgM recalled | Quest International | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |