FDA Device recall Z-1312-2018
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01)
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) by Phadia Us, citing the stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1312-2018 |
| 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 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.
Reason
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Identifiers
| code_info | Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY |
|---|
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-1312-2018%22
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