Class II U.S. Food and Drug Administration

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked recall: Due to distributing the measles IgG IVD without a premarket approved/cleared

Recall published 11 months ago

Due to distributing the measles IgG IVD without a premarket approved/cleared.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to distributing the measles IgG IVD without a premarket approved/cleared.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0534-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Quest International, Inc.
Product type
Medical devices
Distribution
Utah, Washington
Made in
United States
Lot / code info
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
UPC codes
00850487007357

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00850487007357

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • DI# 00850487007357 Lots affected

Model or item number

On the rating label, the box or the instruction sheet.

  • 01-190 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Quest International, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Quest International, Inc. — 8127 Nw 29th St, Doral, FL, 33122-1051

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Quest International, Inc. medical devices recalled?

Due to distributing the measles IgG IVD without a premarket approved/cleared. Due to distributing the measles IgG IVD without a premarket approved/cleared.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00850487007357; lot code DI# 00850487007357 Lots affected; model number 01-190 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Utah, Washington.

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