Recall Z-2596-2018— QIAGEN
Class II · Terminated
Class II FDA medical device recall by QIAGEN, initiated 2018-05-28, terminated 2019-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.. Reason: Underfilled reagent well that could lead to incorrect results.
- Recalling firm
- QIAGEN
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-28
- Terminated
- 2019-04-05
- Firm location
- KOELN, N/A, Germany
Product description
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Reason for recall
Underfilled reagent well that could lead to incorrect results
Data sourced from openFDA. This site is unofficial and independent of the FDA.