Z-2552-2025Class II

Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog...

Name: Z-2552-2025 Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog...
Creator: Quest International, Inc.
Published: 2025-07-17
License: https://open.fda.gov/license/

Quest International, Inc. / initiated 2025-07-17 / Open, Classified

FDA source

Quest International, Inc. began a recall of Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product... on 2025-07-17. FDA classified it as Class II and gives the reason as "Measles IgM Test Kit lacks premarket approval or clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2552-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-17
Posted: 2025-09-11
Recalling firm: Quest International, Inc.
Product: 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
Product code: PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Reason for recall: Measles IgM Test Kit lacks premarket approval or clearance.
FDA root cause: No Marketing Application
Action: On July 17, 2025, Quest International, Inc. issued a "Urgent: Medical Device Recall Notification to affected consignees via E-Mail. Quest International asked consignees to take the following actions: 1. Please examine your inventory and quarantine the affected lot. In addition, if you have distributed the product, you must identify all customers that have received the affected product and immediately notify them. 2. Please ask your customers to discontinue the use of the affected product(s) lot of the Measles IgM Test Kit immediately. 3. We ask that you and your customers discard all affected products in accordance with all local, state, and federal disposal procedures. 4. Please complete and return the enclosed Medical Device Recall Response Form as soon as possible.
Quantity in commerce: 376 kits
Distribution: US Nationwide distribution in the states of Utah, Texas, and Arizona.
Product codes and lots: UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2552-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2552-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11

Product code PCL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)