FDA Device recall Z-1313-2018
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016)
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016) by Phadia Us, citing the stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1313-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-18 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Phadia Us |
| Distribution | US |
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.
Identifiers
| code_info | Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.