Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Instructions for Use (IFU) for Progesterone 3 Calibrator Set Recalled by Tosoh Bioscience, Inc. Due to Instructions For Use had incorrect lot number and...
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
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Quantity: 41 single sets of Progesterone 3 calibrators
Why Was This Recalled?
Instructions For Use had incorrect lot number and calibrator values
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tosoh Bioscience, Inc.
Tosoh Bioscience, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report