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BIOBASE
Biobase Biodustry(Shandong)Co., Ltd. · Model R1:20mL×4 R2:5mL×4 · UDI-DI 06971674861386
9
510(k) clearances
0
Adverse events
4
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-24 | Siemens Healthcare Diagnostics, Inc. | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, |
| 2021-02-03 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipop |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm |
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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.