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.
This recall has been terminated (originally issued December 18, 2017).
- Company
- Phadia Us Inc
- Recall Initiated
- December 18, 2017
- Terminated
- March 27, 2019
- Recall Number
- Z-1313-2018
- Quantity
- 950 total
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Distribution
Nationwide Distribution
Lot / Code Info
Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
Root Cause
Device Design
Action Taken
Customers are being asked to please stop using all current product, and scrap any unused products. Please disregard any reported test result below the assay Limit of Quantification (LoQ 0.1 kUA/l) from the lots, as these results may not be valid. Please note that assay results above the Limit of Quantification, will only be affected by giving a lower result than the real value. Please fill in the Recall Letter Acknowledgement Form provided, including the table in the response form to obtain credit, and return the signed response by e-mail or fax.