ImmunoCAP Allergen c6 — Class II medical device recall Z-1313-2018
Terminated recall by Phadia US Inc, reported 2018-04-11, distributed nationwide. The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
| Recall number | Z-1313-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2017-12-18 |
| Classified | 2018-04-05 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 950 total |
| Reason classes | undeclared allergen, specification failure |
| Lot numbers | 2018.02.28, 2018.04.30, 2018.07.31, 991D7, 991D9, 991DA, 991DC |
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 for recall
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1313-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.