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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 11 of 36

Device	Model / Reference	Registries	Class	Status
Hmb45	NPAI057T40	FDA UDI	Class I	Active
p40 (M)	AVI3066KG	FDA UDI	Class I	Active
Gcdfp-15	CM113B	FDA UDI	Class I	Active
Cd3 (m)	CM110BK	FDA UDI	Class I	Active
CD30 (Ki-1)	PM031AA	FDA UDI	Class I	Active
BCA-225 [Cu-18]	ACI3241A	FDA UDI	Class I	Active
DAB Away	DA000-250-KIT	FDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	PM001H	FDA UDI	Class I	Active
Androgen Receptor	ACI109A	FDA UDI	Class I	Active
Prame [epr20330]	AVI3252G	EUDAMEDFDA UDI	Class I	Active
Intellipath Warp Red Chromogen	IPK5024G80	EUDAMEDFDA UDI	Class I	Active
Ttf-1	IP087G10	FDA UDI	Class I	Active
Cdx2 (rm)	API3144AA	FDA UDI	Class I	Active
MART-1 Cocktail	CM077C	FDA UDI	Class I	Active
Factor XIIIa	AVI357G	FDA UDI	Class I	Active
Diva Decloaker 20X	DV2005L2J	EUDAMEDFDA UDI	Class I	Active
Caspase-3 (Cleaved)	CP229B	FDA UDI	Class I	Active
CD3 [BC33] BSA Free (1.0mg/ml)	ACC3170CFW	FDA UDI	Class I	Active
CK HMW [34BetaE12]	CM127C	FDA UDI	Class I	Active
Cd31 (pecam-1)	CM347A	FDA UDI	Class I	Active
Mlh-1	PM220AA	FDA UDI	Class I	Active
Gross Cystic Disease Fluid Protein-15 (GCDFP-15)	NPAI113T40	FDA UDI	Class I	Active
MACH 1 Universal HRP-Polymer Kit	M1U539G	EUDAMEDFDA UDI	Class I	Active
Uroplakin II	OPAI3051T60	FDA UDI	Class I	Active
Desert Chamber Pro	DRY2008US	FDA UDI	Class I	Active
EMA [Mc-5]	CM143C	FDA UDI	Class I	Active
IGH (14q32) Constant Orange	HFA7278A	FDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	OPAI001T60	FDA UDI	Class I	Active
Estrogen Receptor (ER) [6F11 + SP1]	API308H	FDA UDI	Class II	Active
Van Gogh Diluent	PD902H	EUDAMEDFDA UDI	Class I	Active
ERBB2 (17q12) Red	PFA7274V	FDA UDI	Class I	Active
4+ Biotinylated Goat Anti-Rabbit IgG	GR602H	EUDAMEDFDA UDI	Class I	Active
Heat Shock Protein 70	CM407A	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	ACA135A	FDA UDI	Class I	Active
Atrx	ALI3251G7	FDA UDI	Class I	Active
Cd34	AVI084G	FDA UDI	Class I	Active
Cd3 (p)	CP215A	FDA UDI	Class I	Active
Cdh17 (m)	API3111AA	FDA UDI	Class I	Active
Pax8 (m)	AVI438G	FDA UDI	Class I	Active
Cd3	OPAI324T60	FDA UDI	Class I	Active
CD68 [KP1] BSA Free (1.0mg/ml)	ACC033CF	FDA UDI	Class I	Active
EMA [Mc-5]	CM143B	FDA UDI	Class I	Active
Cyclin D1	ALI432G7	FDA UDI	Class I	Active
Galectin-3	ACI3174B	FDA UDI	Class I	Active
Cd138	IP167G10	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	AVI278G	FDA UDI	Class I	Active
Factor VIII	CP039B	FDA UDI	Class I	Active
Ox40/Cd134	ACI3245C	FDA UDI	Class I	Active
Erg	CM421A	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	VP165G	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.