Phadia US Inc: Medical Device Recall in 2015 - (Recall #: Z-0947-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 20, 2014

Date Posted: January 21, 2015

Recall Number: Z-0947-2015

Event ID: 69872

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.

Status: Terminated

Product Quantity: 146

Code Information:

Part Number 12-3800-01

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.

Voluntary or Mandated:

Voluntary: Firm initiated