Reported Jan 21, 2015 · Terminated
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since…
Phadia US Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Phadia US Inc · 4169 Commercial Ave · Portage, MI · 49002-9701
Is this the product you have?
- Phadia 1000 Instrument (introduced as UniCAP 1000)
- Article number12-3800-01 (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
- Lot codes and dates
- Part Number 12-3800-01
- Amount recalled
- 146
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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