Z-0947-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- November 20, 2014
- Termination Date
- June 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
Code Information
Part Number 12-3800-01