QIAstat-Dx Respiratory SARS-CoV-2 Panel recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…
Why was QIAstat-Dx Respiratory SARS-CoV-2 Panel recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 1474 kits
- Distribution
- 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.
- Recall date
- September 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)