Recall Z-1683-2023— Qiagen Sciences LLC

Name: FDA recall Z-1683-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-28

Class II · Ongoing

Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2023-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223. Reason: Faulty cartridges in the lot could result in false test results..

Recalling firm: Qiagen Sciences LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-04-28
Firm location: Germantown, MD, United States

Product description

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Reason for recall

Faulty cartridges in the lot could result in false test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.