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Terminated

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.

FDA Recall Z-1312-2018 · Posted None

Recalling FirmPhadia US Inc
Recall StatusTerminated
Product CodeDHB
Date Initiated2017-12-18
Date Terminated2019-03-27
Product Quantity950 total

Reason for Recall

The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051218MODIFICATION TO: UNICAP SPECIFIC IGEPharmacia Diagnostics AB · 2005-06-09K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, FPharmacia & Upjohn Co. · 1999-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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