Reported Aug 3, 2016 · Terminated
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use…
Tosoh Bioscience, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience, Inc. · 6000 Shoreline Ct Ste 101 · South San Francisco, CA · 94080-7606
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
- Amount recalled
- 41 single sets of Progesterone 3 calibrators
Where it was sold
Why it was recalled
Instructions For Use had incorrect lot number and calibrator values
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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