Z-2938-2020 Class II Terminated
FDA device recall Z-2938-2020 was initiated by Qiagen Sciences LLC on July 15, 2020 and is designated Class II. Reason for recall: There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis… The recall status is terminated (terminated March 22, 2021). Affected quantity: 1474 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- July 15, 2020
- Termination Date
- March 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1474 kits
Product Description
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
Reason for Recall
There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
Distribution Pattern
US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.
Code Information
lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508