FDA Medical Device Recalls (openFDA)
Qiagen GmbH: 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
- Recall number
- Z-2246-2023
- Recalling firm
- Qiagen GmbH
- 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
- Status
- Open, Classified
- Initiated
- 2023-05-19
- Posted
- 2023-07-27
- Terminated
- not on file
- Reason
- Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
- 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: TechService-NA@qiagen.com
- Quantity
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QLT
- Firm FEI
- 3004013603
- Firm city
- Hilden
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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