Device product
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Z-1313-2018
Product summary
- Firm
- Phadia US Inc
- Event
- Event 79444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 950 total
- Official record key
device-enforcement:Z-1313-2018
Official wording
Reason: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Code information: Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.