Recall Z-0947-2015 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Phadia US Inc
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-s
| Date | Jan 12, 2015 (initiated Nov 20, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of avail |
| Quantity | 146 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121156 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia AB, Mar 13, 2013 |
| K121463 | IMMUNOCAP ALLERGEN K82 Thermo Fisher Scientific, Jan 29, 2013 |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia US, Inc., Aug 28, 2013 |
| K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM Phadia AB, Jun 28, 2013 |
| K131738 | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H Phadia AB, Jul 10, 2013 |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH Phadia AB, Feb 24, 2014 |