Device 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.
Z-2282-2016
Product summary
- Event
- Event 74452
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41 single sets of Progesterone 3 calibrators
- Official record key
device-enforcement:Z-2282-2016
Official wording
Reason: Instructions For Use had incorrect lot number and calibrator values
Code information: Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
Distribution pattern: US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Derived failure modes
-
Unknown
Instructions For Use had incorrect lot number and calibrator values