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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 9 of 36

Device	Model / Reference	Registries	Class	Status
Tacha's Bluing Solution 10X	HTBLU-MX	FDA UDI	Class I	Active
Cd44	PM380AA	FDA UDI	Class I	Active
HPV Type 6 Probe (Digoxigenin)	BRA4045A	FDA UDI	Class I	Active
Chromogranin A	OPAI010T60	FDA UDI	Class I	Active
Pms2	CM344BK	FDA UDI	Class I	Active
Gata-3	AVI405G	FDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	NPAI001T40	FDA UDI	Class I	Active
Hla-Dr [tal 1b5]	ACI3273C	FDA UDI	Class I	Active
Cd4 + Cd8	OPAI3157DS	FDA UDI	Class I	Active
LCA Cocktail	CM016BK	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	ACI301A	FDA UDI	Class II	Active
Progesterone Receptor (PR) [PgR636]	API343AA	FDA UDI	Class I	Active
Cd47 [epr21794]	API3284AA	FDA UDI	Class I	Active
Pan Melanoma + Ki-67	PM362DSH	FDA UDI	Class I	Active
Ido1	ACI3210B	FDA UDI	Class I	Active
Napsin A	IPI388G10	FDA UDI	Class I	Active
Pcna [pc10]	ACI3255C	FDA UDI	Class I	Active
Collagen IV	PM112AA	FDA UDI	Class I	Active
Cd23	CM100A	FDA UDI	Class I	Active
p40 (M), 3X (Prostate)	API3079G3	FDA UDI	Class I	Active
Pd-1	ACI3137CK	FDA UDI	Class I	Active
Microglia (Iba1)	CP290B	FDA UDI	Class I	Active
Cd99	NPAI392T40	FDA UDI	Class I	Active
Gfap (p)	CP040B	FDA UDI	Class I	Active
Claudin-4	ACI3121A	FDA UDI	Class I	Active
Gfap (m)	PM065AA	FDA UDI	Class I	Active
IgG4 (M)	ACI3115A	FDA UDI	Class I	Active
PSAP [rACPP/1338]	API3263AA	FDA UDI	Class I	Active
Vimentin	CM048A	FDA UDI	Class I	Active
Bcl-6 [LN22]	CM410C	FDA UDI	Class I	Active
Cd45ro [uchl-1]	PM006AA	FDA UDI	Class I	Active
MACH 3 Rabbit AP Polymer Detection	M3R533L	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ALR3278G7	FDA UDI	Class I	Active
Cd54 [e3q9n]	API3296AA	FDA UDI	Class I	Active
ROR gamma T	API3208AA	FDA UDI	Class I	Active
Msh6 [bc19]	AVI3215G	FDA UDI	Class I	Active
Copy Control 10 Green	CFA7200A	FDA UDI	Class I	Active
Hpv-16 (camvir-1)	ACI186C	FDA UDI	Class I	Active
HER2/neu [IHC042]	ACA3274B	FDA UDI	Class I	Active
MACH 2 Rabbit HRP-Polymer	RHRP520H	FDA UDI	Class I	Active
Cyclin D1	ALI307G7	FDA UDI	Class I	Active
Mlh-1	NPAI220T40	FDA UDI	Class I	Active
Bcl-6 [LN22]	CM410A	FDA UDI	Class I	Active
p63	CM163C	FDA UDI	Class I	Active
Nkx3.1	PP422AA	FDA UDI	Class I	Active
20q13.2 Orange	PFA7255V	FDA UDI	Class I	Active
Progesterone Receptor [PgR636]	IPI343G10	FDA UDI	Class I	Active
Erg	CM421C	FDA UDI	Class I	Active
Spirochete	ACI135B	FDA UDI	N	Active
Cd34	PM084H	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.