Quest International recalls 376 Measles IgM ELISA kits nationwide in Utah, Texas and Arizona after discovering the product lacks premarket approval or clearance. The high-risk health device carries a Class II designation. Stop using the device immediately and follow manufacturer recall instructions.
Measles IgM Test Kit lacks premarket approval or clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Quest International, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Measles IgM ELISA kits are used in clinical labs to detect recent measles infection by identifying IgM antibodies in patient serum or plasma.
The regulatory gap means the kit has not undergone FDA premarket review, potentially compromising test validity and patient safety.
This recall is not part of a broader industry pattern for misclassified devices.
High risk to clinical accuracy and patient management; clinics may need to halt testing and switch to FDA-cleared alternatives.
Kits display model, lot, and UDI on the exterior label and packaging.
Refund or replacement timelines vary by manufacturer; expect weeks for processing after return.
Keep all recall notices, purchase receipts, lot numbers, and correspondence with the manufacturer.
Brand: Quest International. Product: Measles IgM Enzyme Linked Immunoassay Kit. Model/Catalog: 01-190M. Other models/UDI: UDI I# 00850487007104, lots affected G00024. Quantity: 376 kits. Distribution: US nationwide in Utah, Texas, Arizona.
No incidents or injuries are reported in the provided data. Hazard classification remains high due to regulatory status.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.
ZOLIQUEX recalled adult portable bed rails sold on Amazon after reports of entrapment and asphyxiation risk. The recall targets silver bed rails measuring 12.4 inches wide by 33.07 inches tall and weighing 7.1 pounds. The model numbers ZEX014-V1 and the Zoliquex branding appear on packaging. Stop using the product and seek a full refund by contacting ZOLIQUEX.
Vitaquest International recalled Arey Not Today iron supplements sold at retailers nationwide after determining the products do not meet the Poison Prevention Packaging Act's child-resistant packaging requirement. The noncompliant packaging creates a poisoning risk to young children if ingested. Consumers should stop using the products immediately and contact Vitaquest for a free child-resistant替换
Easymake adult portable bed rails imported by ZFZG-US are recalled on April 9, 2026. The recall cites a risk of entrapment and asphyxiation and notes the product lacks required hazard warning labels. Stop using the recalled rails immediately and contact ZFZG-US for a full refund.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Sangohe expands its 2026 recall of adult portable bed rails 504E and 504Q due to entrapment and asphyxiation risk. The recall cites noncompliance with the mandatory standard and missing warning labels. Stop using the recalled rails and pursue a full refund by contacting Sangohe.
Tuymec Minoxidil Hair Growth Kit sold on Amazon by DrHealBeauty is recalled for non-child-resistant packaging. The kit contains two black spray bottles with 5% minoxidil and BIOTIN labels. Consumers should stop using the product immediately and contact DrHealBeauty for a free empty replacement bottle with a child-resistant closure.
TecFlox recalled its Minoxidil Topical Solution hair growth serum bottles on April 2, 2026. The packaging is not child-resistant, violating the Poison Prevention Packaging Act. Consumers should stop using the product immediately, store it out of reach of children, and email TecFloxrecall@outlook.com to receive free replacement bottles. Only bottles with serum remaining will be replaced; dispose of