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.
Reported: April 11, 2018 Initiated: December 18, 2017 #Z-1312-2018
Product Description
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 for Recall
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Details
- Recalling Firm
- Phadia US Inc
- Units Affected
- 950 total
- Distribution
- Nationwide Distribution
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Phadia US Inc. Units affected: 950 total.
Why was this product recalled? ▼
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1312-2018.
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