FDAClass IIJune 14, 2023

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed recall

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

Why was QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed recalled?

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

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 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Recalling firm
Qiagen Sciences LLC
Quantity
347 kits
Distribution
US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
Recall date
June 14, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls