Recall Z-2282-2016— Tosoh Bioscience, Inc.
Class III · Terminated
Class III FDA medical device recall by Tosoh Bioscience, Inc., initiated 2016-06-07, terminated 2017-02-22. It names one FDA 510(k) clearance: K153417. Product: 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.. Reason: Instructions For Use had incorrect lot number and calibrator values.
- Recalling firm
- Tosoh Bioscience, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-06-07
- Terminated
- 2017-02-22
- Firm location
- South San Francisco, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Instructions For Use had incorrect lot number and calibrator values
Data sourced from openFDA. This site is unofficial and independent of the FDA.