Home › PROMEGA CORPORATION › Maxwell® CSC Genomic DNA Kit
Maxwell® CSC Genomic DNA Kit
PROMEGA CORPORATION · Model AS1850 · UDI-DI 00849811066115
10
510(k) clearances
295
Adverse events (1 deaths)
32
Recalls
97
Facilities
Description
The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from human samples.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-11 | BioMerieux SA | Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to |
| 2024-06-03 | Qiagen Sciences LLC | Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Pr |
| 2024-03-04 | Qiagen Sciences LLC | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample b |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.