Z-2246-2023Class II

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test...

Name: Z-2246-2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test...
Creator: Qiagen GmbH
Published: 2023-05-19
License: https://open.fda.gov/license/

Qiagen / initiated 2023-05-19 / Open, Classified / root cause: manufacturing process

FDA source

Qiagen GmbH began a recall of QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS)... on 2023-05-19. FDA classified it as Class II and gives the reason as "Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2246-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-07-27
Recalling firm: Qiagen
Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Qiagen issued a customer letter (Urgent Medical Device Correction (REF 691223) or Urgent Field Safety notice (REF 691214) via e-mail on 5/19/23. Letter states reason for recall, health risk and action to take: Do not use the remaining stock of cartridges of LOTs 175010704 and 175011354. 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. " 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 02 June 2023. 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: 4155 kits
Distribution: DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA
Product codes and lots: LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2246-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2245-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27
Z-2246-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27

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)