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QIAcuityDx® Universal MasterMix Kit
QIAGEN GmbH · Model 1 · UDI-DI 04053228049432
10
510(k) clearances
315
Adverse events (1 deaths)
30
Recalls
259
Facilities
Description
The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures. The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use. The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel. It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-26 | Immuno-Mycologics, Inc | Neutralization Buffer may contain contaminants |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-10-29 | Copan Italia | Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. |
| 2025-10-29 | Copan Italia | Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. |
| 2025-05-21 | Diagnostica Stago, Inc. | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-09-25 | Biocare Medical, LLC | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may l |
| 2024-05-21 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Sli |
| 2024-02-07 | Beckman Coulter, Inc. | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 33 |
| 2023-05-24 | NeuMoDx Molecular Inc | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.