QIAcube Connect MDx — Class II medical device recall Z-1746-2022
Ongoing recall by Qiagen Sciences LLC, reported 2022-09-21, distributed in AZ, CA, CO, DC, DE, FL, GA, IA…. During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to b
| Recall number | Z-1746-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2021-11-21 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Distributed | AZ, CA, CO, DC, DE, FL, GA, IA, KS, LA, MA, MD, MN, NC, NJ, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI |
| UPC / GTIN / UDI-DI | 04053228039129 |
| Serial numbers | 30000, 30002, 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30010, 30013, 30016, 30019, 30021, 30023, 30025, 30027, 30028, 30031, 30032, 30033, 30034, 30035, 30037, 30039 and 66 more |
| Model numbers | 9003070 |
Product
QIAcube Connect MDx, Model No. 9003070
Reason for recall
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1746-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.