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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 2 of 36

Device	Model / Reference	Registries	Class	Status
Cd71	NPAI3110T40	FDA UDI	Class I	Active
Helicobacter pylori	IP383G10	FDA UDI	Class I	Active
ARCHV – Antigen Retrieval Chamber High Voltage (Recertified)	DCARC0003-R	FDA UDI	Class I	Active
Calponin	PM172AA	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	ACI054A	FDA UDI	Class II	Active
Cytokeratin LMW (8/18)	ALI056G7	FDA UDI	Class I	Active
HMW CK + p63	PM210AA	FDA UDI	Class I	Active
Bcl-2	AVI003G	FDA UDI	Class I	Active
Mlh-1	AVI220G	FDA UDI	Class I	Active
Ctla-4	API3211AA	FDA UDI	Class I	Active
pHH3 (RM)	ACI3130C	FDA UDI	Class I	Active
Calponin	CM172C	FDA UDI	Class I	Active
Factor XIIIa	OPAI357T60	FDA UDI	Class I	Active
Factor XIIIa	IP357G10	FDA UDI	Class I	Active
Myeloperoxidase (P)	PP023H	FDA UDI	Class I	Active
p40 (P)	ALI3030G7	FDA UDI	Class I	Active
B72.3	CM002C	FDA UDI	Class I	Active
Pax8	OPAI379T60	FDA UDI	Class I	Active
MACH 4 Universal AP Detection System	BRI4005L	EUDAMEDFDA UDI	Class I	Active
Sox10 (m)	ACI3099A	FDA UDI	Class I	Active
MACH 2 Mouse AP-Polymer	MALP521H	EUDAMEDFDA UDI	Class I	Active
p40 (P)	AVI3030G	FDA UDI	Class I	Active
Cd68 [kp1]	CM033A	FDA UDI	Class I	Active
Hla-B [bc43]	API3289AA	FDA UDI	Class I	Active
E-Cadherin [CDH1/2208R]	ACI3230C	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3 + 8/18]	API3227AA	FDA UDI	Class I	Active
Insm1 [blr272l]	AVI3299G	FDA UDI	Class I	Active
Leukocyte Common Antigen (LCA Cocktail)	IP016G10	FDA UDI	Class I	Active
E-cadherin	PM170AA	FDA UDI	Class I	Active
Ki-67 [MIB-1]	NPAI3156T80	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (HSA)	CM166C	FDA UDI	Class I	Active
Cd10	IP129G10	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	AVA135G	FDA UDI	Class I	Active
MART-1 Cocktail	CM077B	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	OPAI278T60	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	OPAI062T60	FDA UDI	Class I	Active
Pronase Buffer	PRB957H	EUDAMEDFDA UDI	Class I	Active
Pd-L1	API3171AA	FDA UDI	Class I	Active
Vista [blr035f]	ACI3271C	FDA UDI	Class I	Active
Msh2	PM219AA	FDA UDI	Class I	Active
Cd20 [l26]	OPAI004T60	FDA UDI	Class I	Active
TBSplus 10X	TBS942M	EUDAMEDFDA UDI	Class I	Active
Tumor Associated Glycoprotein [B72.3]	NPAI002T40	FDA UDI	Class I	Active
Cytokeratin 18 (CK 18)	ACI3061A	FDA UDI	Class I	Active
MACH 4 Universal HRP-Polymer Detection System	BRI4012H	FDA UDI	Class I	Active
Cytokeratin HMW	NPAI127T40	FDA UDI	Class I	Active
CD117/c-kit	ALI296G7	FDA UDI	Class I	Active
Cd8 [c8/1779r]	ACI3219C	FDA UDI	Class I	Active
CD3 [BC33] BSA Free (1.0mg/ml)	ACC3170CF	FDA UDI	Class I	Active
Sma	CM001C	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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Notified Bodies

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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.