FDA Medical Device Recalls (openFDA)
Phadia US Inc: 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.
- Recall number
- Z-1313-2018
- Recalling firm
- Phadia US Inc
- 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.
- Status
- Terminated
- Initiated
- 2017-12-18
- Posted
- not on file
- Terminated
- 2019-03-27
- Reason
- The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 950 total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
- 510(k) numbers
- ["K051218","K993388"]
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 3004973408
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28