Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2282-2016 · Posted 2016-07-25

Recalling FirmTosoh Bioscience, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2016-06-07
Date Terminated2017-02-22
Product Quantity41 single sets of Progesterone 3 calibrators

Reason for Recall

Instructions For Use had incorrect lot number and calibrator values

Firm Action

Tosoh Bioscience sent an Urgent Correction Notification letter dated June 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Tosoh Technical Support at 1-800-248-6764.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑