Z-1683-2023Class II

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

Name: Z-1683-2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Creator: Qiagen Sciences LLC
Published: 2023-04-28
License: https://open.fda.gov/license/

Qiagen / initiated 2023-04-28 / Open, Classified

FDA source

Qiagen Sciences LLC began a recall of QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 on 2023-04-28. FDA classified it as Class II and gives the reason as "Faulty cartridges in the lot could result in false test results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1683-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-28
Posted: 2023-06-02
Recalling firm: Qiagen
Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: Faulty cartridges in the lot could result in false test results.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated April 2023 was sent to customers. Actions to be taken by customer/user Please check if you have remaining stock of LOT 175011350. Please DO NOT use it. Dispose of it immediately in accordance to your national and local safety and environmental regulations. Please contact QIAGEN Technical Services for a free-of-charge replacement. If you already used cartridges from this LOT, please identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned in this notice to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed on clinical and/or epidemiological suspicion of the respective targets. Review this notice with your laboratory/medical director. IMPORTANT: Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. Complete the Acknowledgement of Receipt Form attached to this letter by 14 May 2023. Actions taken by QIAGEN QIAGEN was able to identify the root cause of the issue and has implemented immediate actions to ensure that the currently produced cartridges will not cause this issue moving forward. If you have any questions or concerns, please contact your local QIAGEN Technical Services Department through any of the following: Telephone: 800 362 7737 Email: [email protected]
Quantity in commerce: 347 kits
Distribution: US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
Product codes and lots: GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1683-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1683-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-02

Product code QLT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)