Recall Z-0387-2018— Phadia US Inc
Class II · Terminated
Class II FDA medical device recall by Phadia US Inc, initiated 2017-07-05, terminated 2018-10-04. It names 2 FDA 510(k) clearances: K161899, K133404. Product: Phadia 1000 Instrument, Article Number 12-3800-01.. Reason: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results..
- Recalling firm
- Phadia US Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-05
- Terminated
- 2018-10-04
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
2 on FDA's record- K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Phadia 1000 Instrument, Article Number 12-3800-01.
Reason for recall
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.