# FDA recall Z-1313-2018

> **Phadia US Inc** · Class II · device recall initiated 2017-12-18.

## 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.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-1313-2018
- **Recalling firm:** Phadia US Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-18
- **Report date:** 2018-04-11
- **Termination date:** 2019-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2018

## Citation

> AI Analytics. FDA recall Z-1313-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1313-2018. Source: US FDA. Licensed CC0.

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