Recall Z-1313-2018— Phadia US Inc
Class II · Terminated
Class II FDA medical device recall by Phadia US Inc, initiated 2017-12-18, terminated 2019-03-27. It names 2 FDA 510(k) clearances: K051218, K993388. 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.. Reason: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met..
- Recalling firm
- Phadia US Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-18
- Terminated
- 2019-03-27
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
2 on FDA's record- K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE
- K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
K-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
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.
Reason for recall
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Data sourced from openFDA. This site is unofficial and independent of the FDA.