Is this your brand? Sign in to claim ownership.

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 12 of 36

Device	Model / Reference	Registries	Class	Status
Cd8	CRM311C	FDA UDI	Class I	Active
SOX10 [BC34] BSA Free (1.0mg/ml)	ACC3099CF	FDA UDI	Class I	Active
Cyclin D1	IPI307G10	FDA UDI	Class I	Active
Imp3 (rm)	ACI3180A	FDA UDI	Class I	Active
MART-1 Cocktail	PM077H	FDA UDI	Class I	Active
Amacr (rm)	APA3024H	FDA UDI	Class I	Active
Napsin A	OPAI388T60	FDA UDI	Class I	Active
Cdx2	OPAI226T60	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	ACI301C	FDA UDI	Class II	Active
Mash1	API3131AA	FDA UDI	Class I	Active
Cd34	PM084AA	FDA UDI	Class I	Active
HER2/neu [IHC042]	ACA3274A	FDA UDI	Class I	Active
Cd44	NPAI380T40	FDA UDI	Class I	Active
p53	IP298G10	FDA UDI	Class I	Active
Tigit [bc41]	AVI3254G	FDA UDI	Class I	Active
MACH 2 Rabbit AP-Polymer	RALP525L	FDA UDI	Class I	Active
4+ HRP Universal Detection	HP504UM	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	CM278BK	FDA UDI	Class I	Active
Cea (m)	PM058AA	FDA UDI	Class I	Active
DAB Sparkle	DS830M	FDA UDI	Class I	Active
Cd43	CM005A	FDA UDI	Class I	Active
Desmin	CM036C	FDA UDI	Class I	Active
Phospho-Egfr	API300AA	FDA UDI	Class I	Active
CK5/14 + p63 + CK7/18	VP360DSKG	FDA UDI	Class I	Active
Mlh-1	ALI220G7	FDA UDI	Class I	Active
Mouse anti-Digoxigenin	BRI4049G	FDA UDI	Class I	Active
Estrogen Receptor (ER) [6F11]	ACI093C	FDA UDI	Class II	Active
Estrogen Receptor (ER) [6F11]	ACA093C	FDA UDI	Class II	Active
Leukocyte Common Antigen (LCA) Cocktail	OPAI016T60	FDA UDI	Class I	Active
LCA Cocktail	CM016CK	FDA UDI	Class I	Active
Cd47 [epr21794]	ALI3284G7	FDA UDI	Class I	Active
Alk [5a4]	ACI3041A	FDA UDI	Class I	Active
Braf V600e [ve1]	AVI3248G	FDA UDI	Class I	Active
Cd34	NPAI084T80	FDA UDI	Class I	Active
Ck20	PM062AA	FDA UDI	Class I	Active
Renaissance Background Reducing Diluent	PD905L	EUDAMEDFDA UDI	Class I	Active
Pax8 (m)	OPAI438T60	FDA UDI	Class I	Active
D2-40	PM266AA	FDA UDI	Class I	Active
Tigit [bc41]	ACI3254C	FDA UDI	Class I	Active
Moc-31	OPAI403T60	FDA UDI	Class I	Active
Pd-1 [cal20]	API3224AA	FDA UDI	Class I	Active
Clusterin	ACI218A	FDA UDI	Class I	Active
Ifng [ifng/3996r]	ACI3266A	FDA UDI	Class I	Active
Cd20 [bc30]	ACI3287A	FDA UDI	Class I	Active
Cd8 [c8/144b]	API3160AA	FDA UDI	Class I	Active
Cd31	CM303A	FDA UDI	Class I	Active
Prame [epr20330]	ACI3252C	FDA UDI	Class I	Active
WT1 [rWT1/857]	API3238AA	FDA UDI	Class I	Active
Trim29	PP416AA	FDA UDI	Class I	Active
Copy Control 17 Green	PFA7225V	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.