Measles antibody tests recalled for being distributed without premarket clearance
Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites the absence of premarket clearance rather than any identified defect or reported harm.
Plain-English summary
The ReQuest Measles IgG, a Rubeola IgG enzyme linked immunosorbent assay, catalog number 01-190, from Quest International, is being recalled.
The recall follows distribution of the measles IgG in vitro diagnostic without premarket approval or clearance.
The recall covers lots L07024 and E03025, carrying DI 00850487007357. The product was distributed in Utah and Washington. The FDA has classified the action as Class II.
The enforcement record describes a missing premarket authorisation rather than an identified performance defect, and reports no injuries. Laboratories holding affected lots should follow the firm's instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Quest International, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Distribution
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