FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
- Recall number
- Z-0455-2022
- Recalling firm
- Qiagen Sciences LLC
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
- Status
- Terminated
- Initiated
- 2021-11-08
- Posted
- not on file
- Terminated
- 2023-03-29
- Reason
- The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
- Root cause
- Employee error
- Action
- On November 8, 2021, the firm began notifying customers. Customers received an Urgent Medical Device Correction Notice via email. Customers were instructed to do the following: - Please check the cartridge SNs received from LOT 210209 against the list of affected cartridges shown in Table 1 (page 1). If you have received one of the affected cartridges, please contact QIAGEN Technical Service for a free-of-charge replacement. - If you have received one of the 16 affected cartridges and have not used it, please dispose of it immediately in accordance with your national and local safety and environmental regulations. - If you already used one of the affected cartridges from this LOT, please identify the results obtained with the affected SNs listed on Table 1 (page 1). For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned on page 1 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. - If you have remaining stocks from LOT 210209, cat. no 691223 with cartridge SNs not found in the list, you may still use these cartridges, as this issue is limited to the 16 cartridges listed on Table 1 (page 1). - 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 attached to the letter by November 22, 2021. 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
- 376 kits
- Distribution
- Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
- Lot, serial or model codes
- LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567
- 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
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