QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

FDA device recall Z-1683-2023 · posted 2023-06-02 · Open, Classified

Recall details

Recalling firm

Qiagen Sciences LLC

Reason for recall

Faulty cartridges in the lot could result in false test results.

Action taken

An Urgent Medical Device Correction notification letter dated April 2023 was sent to customers. Actions to be taken by customer/user Please check if you have remaining stock of LOT 175011350. Please DO NOT use it. 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. If you already used cartridges from this LOT, please identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned in this notice 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. 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 14 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QLT

Quantity affected

347 kits

Distribution

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Date initiated

2023-04-28

Date posted

2023-06-02

Location

Germantown, MD