CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016) recalled
Phadia US is recalling ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016), distributed nationwide in the US. The recall was initiated on 18 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1313-2018
- FDA event ID
- 79444
- Recalling firm
- Phadia US, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2017
- FDA classified
- 5 Apr 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Dec 2017 | Recall initiated by company | |
| 5 Apr 2018 | Classified by FDA | +108 days |
| 11 Apr 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Which lots are affected?
Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79444This product is part of a recall event; the main page for the event is ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) recalled | Phadia US | Labeling Errors | Nationwide |
More recalls from Phadia US
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EliA GliadinDP IgG Well in the Phadia 2500EE instrument recalled | Phadia US | Other | CA, MI, NJ |
| Device | CLASS II | Phadia 2500EE instrument -Intended recalled by Phadia US | Phadia US | Other | CA, MI, NJ |
| Device | CLASS II | EliA dsDNA Well recalled by Phadia US | Phadia US | Other | Nationwide |
| Device | CLASS II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) recalled | Phadia US | Labeling Errors | Nationwide |
| Device | CLASS II | Phadia 1000 Instrument, Article Number recalled by Phadia US | Phadia US | Potency & Assay | Nationwide |
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