Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (I
FDA device recall Z-2282-2016 · posted 2016-07-25 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- Reason for recall
- Instructions For Use had incorrect lot number and calibrator values
- Action taken
- 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
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 41 single sets of Progesterone 3 calibrators
- Distribution
- US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
- Date initiated
- 2016-06-07
- Date posted
- 2016-07-25
- Date terminated
- 2017-02-22
- Location
- South San Francisco, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |