Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 26, 2025
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
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quest International, Inc. recalled Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant … - a moderate-severity action.
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant … was recalled by Quest International, Inc. in November 26, 2025. Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared.. Check the official notice for the remedy. Verify recall #Z-0534-2026 with the FDA Devices before acting.
The recall
Quest International, Inc. issued this moderate-severity FDA Devices recall-Due to distributing the measles IgG IVD without a premarket approved/cleared..
- Moderate
- severity level
- Class II
- classification
- November 26, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0534-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0534-2026) was formally reported on November 26, 2025, with the manufacturer initiating the action on October 1, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Quest International, Inc. is listed as the recalling firm, operating out of Doral, FL. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Due to distributing the measles IgG IVD without a premarket approved/cleared. Distribution data in the federal record shows the product reached: All products were distributed in the United States. (Utah, Washington).. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0534-2026 |
| Date reported | November 26, 2025 |
| Date initiated | October 1, 2025 |
| Recalling firm | Quest International, Inc. |
| Firm location | Doral, FL |
| Affected scope | Not disclosed |
| Distribution | All products were distributed in the United States. (Utah, Washington). |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0534-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Quest International, Inc..
Why was this product recalled? ▼
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0534-2026.
Where was the recalled product distributed? ▼
Distribution: All products were distributed in the United States. (Utah, Washington)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0534-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.