Class 2 Device Recall QIAstatDx

• Date Initiated by Firm: March 12, 2025
• Date Posted: March 31, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1504-2025
• Recall Event ID: 96521
• 510(K)Number: K233100
• Product Classification: Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
• Product: Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
• Code Information: REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 332168964 332168972 332168978 332168979 332168980 332168990 332168996 332169005 332169012 332169013 332169015 332169016 332169021 332169022 332169023 332169024 332169031 332169032 332169033 332169034 332169039 332169040 332169041 332169042 332169047 332169048 332169049 332169050 332169055 332169056 332169057 332169060 332169065 332169066 332169073 332169074 332169083 332169084 332169085 332169086 332169091 332169092 332169093 332169094 332169099 332169101 332169102 332169107 332169108 332169109 332169110 332169115 332169116 332169117 332169118 332169123 332169125 332169126 332169131 332169132 332169133 332169134 332169139 332169140 332169141 332169142 332169147 332169148 332169149 332169150 332169155 332169156 332169157 332169158 332169163 332169164 332169165 332169166 332169171 332169172 332169173 332169174 332169180 332169181 332169182 332169187 332169188 332169189 332169190 332169195 332169196 332169197 332169198 332169203 332169204 332169205 332169206 332169212 332169213 332169214 332169216 332169221 332169222 332169223 332169224 332169229 332169230 332169231 332169232 332169238 332169239 332169240 332169241 332169246 332169247 332169248 332169249 332169255 332169256 332169257 332169262 332169263 332169264 332169265 332169271 332169272 332169273 332169279 332169280 332169282 332169287 332169288 332169289 332169290 332169295 332169296 332169297 332169298 332169303 332169315 332169320 332169321 332169322 332169323 332169328 332169329 332169330 332169331 332169336 332169337 332169338 332169339 332169344 332169345 332169346 332169347 332169354 332169355 332169360 332169361 332169362 332169365 332169368 332169369 332169370 332169371 332169376 332169377 332169378 332169379 332169384 332169385 332169386 332169387 332169392 332169393 332169394 332169395 332169401 332169403 332169410 332169412 332169413 332169418 332169420 332169427 332169428 332169429 332169434 332169442 332169443 332169460 332169475 332169477 332169483 332169484 332169486
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: QIAGEN Technical Services; 800-362-7737
• Manufacturer Reason for Recall: Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On March 12, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Actions to be taken by customer/user: 1. Check if you have remaining stock. DO NOT use it. Dispose of it immediately in accordance with your national and local safety and environmental regulations. 2. Contact QIAGEN Technical Services for a free-of-charge replacement. o If you already used cartridges from this LOT, identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN: Review all results of the respective targets mentioned in Detailed description of the issue, above, to identify potentially erroneous diagnosis, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed, or treatments were given on clinical and/or epidemiological suspicion of the respective targets. 3. Review this notice with your laboratory/medical director. 4. Important: Forward this information to all individuals and departments within your organization using the above-listed kits. If you are not the end user, forward this notice to the product end user. 5. Complete the Acknowledgement of Receipt Form 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
• Quantity in Commerce: 445 units
• Distribution: US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QOF