Tosoh Bioscience, Inc. recalls Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (…
- Recall date
- June 7, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2282-2016
- FDA classification
- Class III
- Brand / firm
- Tosoh Bioscience, Inc.
- Sold / distributed
- US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Why it was recalled
Instructions For Use had incorrect lot number and calibrator values
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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