QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended recall
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following…
Why was QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended recalled?
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783
- Product
- QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following…
- Recalling firm
- Qiagen GmbH
- Quantity
- 368 kits
- Distribution
- AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA
- Recall date
- August 2, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)