Qiagen Sciences LLC: QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

Recall number

Z-2938-2020

Recalling firm

Qiagen Sciences LLC

Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

Status

Terminated

Initiated

2020-07-15

Posted

not on file

Terminated

2021-03-22

Reason

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.

Root cause

Material/Component Contamination

Action

On July 15, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers to inform them of the increased rate of potential false positive results for the Influenza A (no subtype) target. Customers were instructed to do the following: l -Please review and reassess all Influenza A (no subtype) positive samples tested with the affected lots. -Please note that as per Instructions for Use if only an Influenza A signal is present and no additional signal for any of the subtypes is generated, it can be due to either low concentration or, in very rare cases, a new variant or any Influenza A strain other than H1 and H3 (e.g., H5N1, which can infect humans). Such result should, therefore, be interpreted in the context of epidemiological and clinical plausibility. -If you have used the affected lot/s and you have concerns about previously generated Influenza A (no subtype) positive results on the basis of which patient treatment/management was initiated, we recommend a review of the corresponding Influenza A (no subtype) positive results. -For continued use of the affected QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 LOTs, Flu A (no subtype) positive results should be retested with an alternate method and interpreted in the context of current epidemiology and clinical presentation. -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. -Please complete Acknowledgement of Receipt attached to this letter by 29 July 2020. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com

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.

Lot, serial or model codes

lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508

510(k) numbers

not on file

PMA numbers

not on file

Product code

QLT

Firm FEI

3003572099

Firm city

Germantown

Firm state

MD

Firm country

not on file

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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