Recall Z-0455-2022— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2021-11-08, terminated 2023-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223. Reason: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-08
- Terminated
- 2023-03-29
- Firm location
- Germantown, MD, United States
Product description
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Reason for recall
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
Data sourced from openFDA. This site is unofficial and independent of the FDA.