Recall record at a glance
| Official record | Z-1312-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Phadia US Inc. |
| Report date | Apr 11, 2018 |
| Recall initiation date | Dec 18, 2017 |
| Quantity | 950 total |
| Location | Portage, MI, United States |
Official product description
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.
Why the product was recalled
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Distribution information
Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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