Device product
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). 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-1312-2018
Product summary
- Firm
- Phadia US Inc
- Event
- Event 79444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 950 total
- Official record key
device-enforcement:Z-1312-2018
Official wording
Reason: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Code information: Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.