Phadia ImmunoCAP Allergen c5 Ampicilloyl Recall: Stability Issues
Phadia recalls ImmunoCAP Allergen c5 Ampicilloyl (article 14-4450-01) due to stability problems. This affects specific IgE test kits with lot numbers 990DS through 990DY.
Lower-risk recall
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Contact the company
What happened, in plain English
Phadia is recalling ImmunoCAP Allergen c5 Ampicilloyl test kits because they may not meet stability requirements. This could lead to inaccurate allergy test results if used after the expiration date. Read more at govinfonow.com/recall/72295-phadia-immunocap-allergen-c5-ampicilloyl-recall-stability-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/72295-phadia-immunocap-allergen-c5-ampicilloyl-recall-stability-issues · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1312-2018
Cite this page
“Phadia ImmunoCAP Allergen c5 Ampicilloyl Recall: Stability Issues.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72295-phadia-immunocap-allergen-c5-ampicilloyl-recall-stability-issues. Based on FDA recall #Z-1312-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2018%22&limit=1).
Why it’s dangerous
The test kits may not meet stability specifications, meaning they could become inaccurate after the expiration date. This could lead to incorrect allergy test results if used beyond their expiration dates.
Who’s affected
People who own or use ImmunoCAP Allergen c5 Ampicilloyl test kits with lot numbers 990DS through 990DY are affected. Those using these kits for allergy testing are most at risk of inaccurate results.
How to tell if you have this one
Check the lot number on the test kit, which is listed as 990DS, 990DT, 990DW, 990DX, or 990DY. These kits were sold with expiration dates up to December 31, 2017, through May 31, 2018.
- Brand
Phadia- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Distribution
| Recall number | Product, codes & lots |
|---|---|
| Z-1312-2018 | 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.; Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY |
| Z-1313-2018 | 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.; Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28 |
What to do — step by step
Check Kit Expiration
Look for the lot number on the test kit to confirm it is one of 990DS, 990DT, 990DW, 990DX, or 990DY.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1312-2018 (December 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1312-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.