Home › SEEGENE, INC. › STARMag 96x4 Universal Plus Cartridge Kit
STARMag 96x4 Universal Plus Cartridge Kit
SEEGENE, INC. · Model 1 · UDI-DI 08809240000069
JJH
Prescription
10
510(k) clearances
294
Adverse events (1 deaths)
31
Recalls
99
Facilities
Description
for isolation of nucleic acid from serum, plasma, and whole blood specimen using automated liquid handling instrument
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2022-11-02 | Qvella Corporation | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to |
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.