Qiagen GmbH: QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

Recall number

Z-2215-2023

Recalling firm

Qiagen GmbH

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 organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

Status

Open, Classified

Initiated

2023-05-09

Posted

2023-07-21

Terminated

not on file

Reason

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

Root cause

Mixed-up of materials/components

Action

Qiagen issued Urgent Medical Device Correction Correction letter via e-mail on 5/9/23. For bounced e-mails, alternative suitable contacts will be identified. Letter states reason for recall, health risk and action to take: Please check if you have remaining stock of LOT 175010712. Do not use the remaining stock of cartridges of LOT 175010712. 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. 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 19. 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: TechService-NA@qiagen.com

Quantity

368 kits

Distribution

AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA

Lot, serial or model codes

GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783

510(k) numbers

not on file

PMA numbers

not on file

Product code

QJR

Firm FEI

3004013603

Firm city

Hilden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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