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BIOER MagaBio plus Virus DNA /RNA Purification Kit III
Hangzhou Bioer Technology Co., Ltd. · Model BSC86S1S · UDI-DI 06973843228457
10
510(k) clearances
295
Adverse events (1 deaths)
32
Recalls
97
Facilities
Description
For the detail information, please refer to the IFU.
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. |
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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.