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B72.3
BIOCARE MEDICAL LLC · Model CM002B · UDI-DI 00847627005366
NJT
Prescription
0
510(k) clearances
50
Adverse events (1 deaths)
92
Recalls
45
Facilities
Description
Alternate name : Tumor Associated Glycoprotein [B72.3]
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2024-06-27 | Ventana Medical Systems, Inc. | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. |
| 2021-07-30 | Leica Microsystems, Inc. | Product may not perform as specified in IFU. |
| 2021-07-15 | Cell Marque Corporation | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely t |
| 2019-11-18 | Leica Microsystems, Inc. | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. |
| 2019-10-10 | Biocare Medical, LLC | Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining |
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
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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.