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Sign in to claim this brandBIOCARE MEDICAL, LLC
United States·US-MF-000034581
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 60, Berry Drive, Pacheco, United States
- Website
- www.biocaremedical.com
- —
- —
- [email protected]
- Phone
- 1(855) 504-9997
- PRRC Contact
- Pia Carusi
- EUDAMED SRN
- US-MF-000034581
- FDA FEI Number
- 3004140393
- DUNS Number
- —
Catalogue (1765)
Page 22 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Myeloperoxidase | PP023AA | FDA UDI | Class I | Active |
| Treponema pallidum (Spirochete) | ACA135C | FDA UDI | Class I | Active |
| D2-40 (Lymphatic Marker) | ALI266G7 | FDA UDI | Class I | Active |
| Nkx3.1 [d2y1a] | ACI3260A | FDA UDI | Class I | Active |
| Cytokeratin 7 (CK7) | IPI061G10 | FDA UDI | Class I | Active |
| Cytokeratin 5/14 Cocktail | API3025AA | FDA UDI | Class I | Active |
| Helicobacter pylori | CM383C | FDA UDI | Class I | Active |
| Monet Blue Diluent | PD901M | FDA UDI | Class I | Active |
| p53 | PME298AA | FDA UDI | Class I | Active |
| Ca 19-9 | NPAI123T40 | FDA UDI | Class I | Active |
| intelliPATH Folate Receptor alpha IHC Assay Kit | IPI4006KG10 | FDA UDI | Class I | Active |
| Mcm2 + Top2a | NPAI3181T40 | FDA UDI | Class I | Active |
| Arginase-1 | API3058AA | FDA UDI | Class I | Active |
| Warp Red Chromogen Kit | WR806M | EUDAMEDFDA UDI | Class I | Active |
| Melan A (M) | ACI3114B | FDA UDI | Class I | Active |
| p40 (P) | ACI3030A | FDA UDI | Class I | Active |
| Ck 5/6 | CM105C | FDA UDI | Class I | Active |
| Msh6 | PM265H | FDA UDI | Class I | Active |
| Estrogen Receptor (ER) [6F11] | API093AA | FDA UDI | Class II | Active |
| Estrogen Receptor (ER) [SP1] | ACA301A | FDA UDI | Class II | Active |
| EcoMount | EM897L | FDA UDI | Class I | Active |
| Trbc1 | API3280AA | FDA UDI | Class I | Active |
| Desmoglein 3 + p40 (M) + Napsin A (RM) | API3132DSAA | FDA UDI | Class I | Active |
| Cytokeratin LMW (8/18) | OPAI056T60 | FDA UDI | Class I | Active |
| Erg (m), 2x | API3017AAK | FDA UDI | Class I | Active |
| Bap1 | ACI3247A | FDA UDI | Class I | Active |
| Prame [epr20330] | ALI3252L | FDA UDI | Class I | Active |
| Ema [e29] | API3038AA | FDA UDI | Class I | Active |
| Cea (m) | CM058A | FDA UDI | Class I | Active |
| Hla-Dr [tal 1b5] | ALI3273G7 | FDA UDI | Class I | Active |
| Ck7 | PRM339AA | FDA UDI | Class I | Active |
| Adipophilin | API3138AA | FDA UDI | Class I | Active |
| RISH™ Kappa Light Chain DNA Probe | BRA0004T | FDA UDI | Class I | Active |
| p16 INK4a [BC42] | AVI3231G | FDA UDI | Class I | Active |
| p63 | NPAI163T80 | FDA UDI | Class I | Active |
| hCG (Beta) | PP124AA | FDA UDI | Class I | Active |
| Msh6 | ALI265G7 | FDA UDI | Class I | Active |
| Glycophorin A [JC159] | ACI3272A | FDA UDI | Class I | Active |
| Stat6 [ye361] | API3244AA | FDA UDI | Class I | Active |
| S100 Protein [4C4.9] (M) | API3237H | FDA UDI | Class I | Active |
| Cd99 | CME392A | FDA UDI | Class I | Active |
| Bcl-2 | CM003C | FDA UDI | Class I | Active |
| E-cadherin | OPAI170T60 | FDA UDI | Class I | Active |
| Caspase-3 (Cleaved) | CP229A | FDA UDI | Class I | Active |
| Ca 19-9 | AVI123G | FDA UDI | Class I | Active |
| Inhibin, Alpha | CM171B | FDA UDI | Class I | Active |
| Ttf-1 | PM087H | FDA UDI | Class I | Active |
| Msh6 | OPAI265T60 | FDA UDI | Class I | Active |
| Adipophilin | NPAI3138T40 | FDA UDI | Class I | Active |
| Cd138 | CM167BK | FDA UDI | Class I | Active |
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FDA Recalls (11)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 25, 2024 | Z-0315-2025 | — | open, classified | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated. |
| Feb 25, 2021 | Z-1333-2021 | — | terminated | Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations. |
| Oct 10, 2019 | Z-2291-2020 | — | terminated | 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. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis. |
| Apr 24, 2018 | Z-2360-2018 | — | terminated | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. |
| Mar 15, 2018 | Z-3198-2018 | — | terminated | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. |
| Mar 31, 2016 | Z-1523-2016 | — | terminated | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer. |
| Sep 8, 2015 | Z-0252-2016 | — | terminated | Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. |
| May 6, 2015 | Z-1676-2015 | — | terminated | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. |
| Mar 17, 2015 | Z-1535-2015 | — | terminated | A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. |
| Dec 12, 2014 | Z-0965-2015 | — | terminated | Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed. |
| Mar 13, 2012 | Z-1392-2012 | — | terminated | Reports of sporadic failure of specific lots of Vina Green Chromogen Kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen. |