Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for Recalled by Tosoh Bioscience Inc Due to Decreased stability for five (5) lots of Calibrator...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.
Affected Products
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Quantity: 289 boxes
Why Was This Recalled?
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tosoh Bioscience Inc
Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report