Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phadia 1000 Instrument (introduced as UniCAP 1000) Recalled by Phadia US Inc Due to During an investigation of instrument logs it was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Phadia US Inc directly.
Affected Products
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
Quantity: 146
Why Was This Recalled?
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Phadia US Inc
Phadia US Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report