Quest recalls measles IgG test kits (model 01-190) distributed without FDA premarket approval. These tests may not be accurate and could lead to incorrect health decisions.
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Quest is recalling measles Ig:G test kits (model 01-190) because they were distributed without FDA premarket approval. This could lead to inaccurate test results and incorrect health decisions.
These tests were distributed without FDA premarket approval, meaning they may not meet accuracy standards. Inaccurate results could lead to incorrect health decisions, such as unnecessary treatment or missed diagnoses.
People who purchased or use the Rubeola IgG Enzyme Linked Immunoabsorbant Assay test kits (model 01-190) from Quest. Those most at risk are individuals relying on these tests for measles antibody detection.
Check for model number 01-190 on the test kit. Affected lots are L07024 and E03025. The product description includes 'Measles IgG tests using ELISA method'.
Look for model number 01-190 and affected lots L07024 or E03025 on the test kit.
Quest distributed these measles IgG tests without FDA premarket approval, which may result in inaccurate results.
Check the model number and lot code on the test kit. If it matches model 01-190 and affected lots L07024 or E03025, contact Quest for guidance.
No, this is a low-risk recall as the hazard is inaccurate test results, not physical harm.
We’ve drafted a message you can send Quest to request your refund or repair — edit it as you like.
Subject: Recall Z-0534-2026 — Quest Quest Hello, I own a Quest that is covered by recall Z-0534-2026 from Quest. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
