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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 28 of 36

Device	Model / Reference	Registries	Class	Status
Helicobacter pylori [EPR10353]	ACA3291A	FDA UDI	Class I	Active
CD117/c-kit	PME296AA	FDA UDI	Class I	Active
Edgar Degas Eosin	HTE-GL	FDA UDI	Class I	Active
MART-1 Cocktail	PM077AA	FDA UDI	Class I	Active
EMA [Mc-5]	CM143A	FDA UDI	Class I	Active
TBS Auto Wash Buffer 20X	TWB945M	EUDAMEDFDA UDI	Class I	Active
P27 Kip1 [y236]	ACI3282A	FDA UDI	Class I	Active
Neurofilament	PM066AA	FDA UDI	Class I	Active
Uroplakin II	ACI3051C	FDA UDI	Class I	Active
p40 (P)	NPAI3030T80	FDA UDI	Class I	Active
EDTA Decloaker 5X	CB917L	EUDAMEDFDA UDI	Class I	Active
5p15.2 Red	CFA7251A	FDA UDI	Class I	Active
D2-40 (Lymphatic Marker)	NPAI266T40	FDA UDI	Class I	Active
Hla-Dr [tal 1b5]	API3273AA	FDA UDI	Class I	Active
20% Tween 20	TWN20M	FDA UDI	Class I	Active
Pms2	IPI344G10	FDA UDI	Class I	Active
Cmv	OPAA118T60	FDA UDI	Class I	Active
Ck19	CM242A	FDA UDI	Class I	Active
Ki-67 [MIB-1]	ALI3156G7	FDA UDI	Class I	Active
Desmoglein 3	CM419C	FDA UDI	Class I	Active
Tia-1	OPAI130T60	FDA UDI	Class I	Active
Ck7	CM061A	FDA UDI	Class I	Active
Borg Decloaker RTU	BD1000MM	FDA UDI	Class I	Active
Cdx2 + Ck7	PM367DSH	FDA UDI	Class I	Active
Igf-1r	CM414C	FDA UDI	Class I	Active
Ttf-1 [spt24]	OPAI3126T60	FDA UDI	Class I	Active
Topoisomerase II alpha	API3045AA	FDA UDI	Class I	Active
CD11c (Leu-M5)	ACI3122A	FDA UDI	Class I	Active
Satb2 [cl0323]	ALI3259G7	FDA UDI	Class I	Active
Decloaking Chamber™ NxGen Reconditioned	DC2012-R	FDA UDI	Class I	Active
Cdx2 + Ck7	PM367DSAA	FDA UDI	Class I	Active
intelliPATH FLX™ Pepsin	IPE5007G20	FDA UDI	Class I	Active
Sox2	ACI3109C	FDA UDI	Class I	Active
Cd138	CM167AK	FDA UDI	Class I	Active
Amyloid P	PP132AA	FDA UDI	Class I	Active
Cdh17 (m)	ACI3111A	FDA UDI	Class I	Active
Progesterone Receptor (PR) [PgR636]	ALA343G7	FDA UDI	Class I	Active
Cd20 [l26]	PM004H	FDA UDI	Class I	Active
HMW CK + p63	OPAI210T60	FDA UDI	Class I	Active
Melanoma Cocktail	CM078C	FDA UDI	Class I	Active
SOX10 [BC34] BSA Free (1.0mg/ml)	ACC3099CFW	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	PM165AA	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	OPAI3154T60	FDA UDI	Class I	Active
Copy Control 3 Aqua	CFA7164A	FDA UDI	Class I	Active
H3K27me3 [C36B11]	ACI3249A	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	CM062A	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	NPAI011T40	FDA UDI	Class I	Active
Cd8	CRM311A	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	ALI3154DSG7	FDA UDI	Class I	Active
p40 (M)	ACI3066A	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

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.