Z-1312-2018Class II

ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro...

Name: Z-1312-2018 ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro...
Creator: Phadia US Inc
Published: 2017-12-18
License: https://open.fda.gov/license/

Phadia AB / initiated 2017-12-18 / Terminated / root cause: design

FDA source

Phadia US Inc began a recall of ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen... on 2017-12-18. FDA classified it as Class II and gives the reason as "The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1312-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Posted: 2018-04-05
Terminated: 2019-03-27
Recalling firm: Phadia AB
Product: 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.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
Reason for recall: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Root cause tag: design
FDA 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 in commerce: 950 total
Distribution: Nationwide Distribution
Product codes and lots: Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-05
Z-1313-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-05

Product code DHB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)