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BIOCARE 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
LinkedIn: —
Facebook: —
Email: [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 16 of 36

Device	Model / Reference	Registries	Class	Status
P504s (p)	APA200H	FDA UDI	Class I	Active
Decloaking Chamber™ NxGen	DC2012-220V	FDA UDI	Class I	Active
Slide Brite	SBT-G1	FDA UDI	Class I	Active
Cd163	NPAI353T40	FDA UDI	Class I	Active
Stat6 [ye361]	AVI3244G	FDA UDI	Class I	Active
CK5 + p63	PM235H	FDA UDI	Class I	Active
Nkx3.1	NPAI422T40	FDA UDI	Class I	Active
CD117/c-kit	CME296AK	FDA UDI	Class I	Active
CD8 [C8/144B] BSA Free (1.0mg/ml)	ACC3160CF	FDA UDI	Class I	Active
CK5/14 + p63 + CK7/18	OPAI360T60	FDA UDI	Class I	Active
Cd10	NPAI129T40	FDA UDI	Class I	Active
Hhv-8 [13b10]	OPAA3290T60	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	ACI3277C	FDA UDI	Class I	Active
p53 Tumor Suppressor Protein (M)	CM042C	FDA UDI	Class I	Active
Mesothelin	ACI3175B	FDA UDI	Class I	Active
HPV Type 18 Probe (Digoxigenin)	BPA4048T60	FDA UDI	Class I	Active
Ferangi Blue™ Chromogen Kit 2	FB813H	FDA UDI	Class I	Active
Glypican-3	CM396B	FDA UDI	Class I	Active
ARC – Antigen Retrieval Chamber	DCARC0001	FDA UDI	Class I	Active
DAB Chromogen Kit	DB801L	FDA UDI	Class I	Active
B72.3	CM002B	FDA UDI	Class I	Active
Da Vinci Green Diluent	PD900L	FDA UDI	Class I	Active
Sox10 (m)	API3099H	FDA UDI	Class I	Active
Cd3	ALI324G7	FDA UDI	Class I	Active
Mcm2 + Top2a	API3181H	FDA UDI	Class I	Active
H3K27me3 [C36B11]	OPAI3249T60	FDA UDI	Class I	Active
Calponin	CM172A	FDA UDI	Class I	Active
Cea (m)	CM058B	FDA UDI	Class I	Active
Pan Cytokeratin [Lu-5]	VP043G	FDA UDI	Class I	Active
c-erbB-2/HER2	NPAA342T80	FDA UDI	Class I	Active
Glycophorin A [JC159]	ALI3272G7	FDA UDI	Class I	Active
Atrx	ACI3251C	FDA UDI	Class I	Active
p63	NPAI163T40	FDA UDI	Class I	Active
intelliPATH™ Negative Control (ER/PR)	IPI5034G20	FDA UDI	Class I	Active
H3K27me3 [C36B11]	ALI3249G7	FDA UDI	Class I	Active
Amacr (rm)	OPAA3024T60	FDA UDI	Class I	Active
Cd39 [epr20627]	API3283AA	FDA UDI	Class I	Active
Cd8	NPAI311T40	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	OPAI3237T60	FDA UDI	Class I	Active
Glutamine Synthetase	ACI3009B	FDA UDI	Class I	Active
Ki-67 [MIB-1]	AVI3156G	FDA UDI	Class I	Active
Afp	PP028AA	FDA UDI	Class I	Active
Ki-67 + CK7/8/18	API3192DSAA	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	OPAI3270T60	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (HSA)	NPAI166T40	FDA UDI	Class I	Active
P504s-2x	IP365G10	FDA UDI	Class I	Active
HER2/neu [IHC042]	APA3274AA	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ACR3278C	FDA UDI	Class I	Active
p120 Catenin	API3008AA	FDA UDI	Class I	Active
Cdh17 (m)	ACI3111C	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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Authorities

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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.