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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 20 of 36

Device	Model / Reference	Registries	Class	Status
p40 [BC28] BSA Free (1.0mg/ml)	ACC3066CF	FDA UDI	Class I	Active
Cd163	CM353AK	FDA UDI	Class I	Active
RISH™ Kappa Light Chain DNA Probe	OPPA0004T60	FDA UDI	Class I	Active
Msh6	AVI265G	FDA UDI	Class I	Active
Kappa Light Chain [L1C1]	API3149AA	FDA UDI	Class I	Active
Hmb45	CM057A	FDA UDI	Class I	Active
Glycophorin A [JC159]	AVI3272G	FDA UDI	Class I	Active
p53	CME298BK	FDA UDI	Class I	Active
Neurofilament	CM066B	FDA UDI	Class I	Active
Copy Control 15 Orange	PFA7218V	FDA UDI	Class I	Active
D2-40 (Lymphatic Marker)	OPAI266T60	FDA UDI	Class I	Active
p40 (M)	OPAI3066T60	FDA UDI	Class I	Active
Idh1 R132h [ihc132]	API3253AA	FDA UDI	Class I	Active
Ck7	CM061C	FDA UDI	Class I	Active
Cd10	OPAI129T60	FDA UDI	Class I	Active
I.E.D. Unit (Ion-Exchange Decal Unit)	IED1203	FDA UDI	Class I	Active
Cd20 [l26]	CM004C	FDA UDI	Class I	Active
Ctla-4	ACI3211A	FDA UDI	Class I	Active
Uroplakin II	NPAI3051T40	FDA UDI	Class I	Active
Cd39 [epr20627	ACI3283C	FDA UDI	Class I	Active
Intellipath™ Background Punisher	IP974G20	EUDAMEDFDA UDI	Class I	Active
Copy Control 3 Aqua	PFA7164V	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	API3237AA	FDA UDI	Class I	Active
intelliPATH Plus	IPPLS0001US-R	FDA UDI	Class I	Active
RISH™ RNA Negative Control Probe	OPPA4029T60	FDA UDI	Class I	Active
Pms2	CM344AK	FDA UDI	Class I	Active
Npm1	ACI3281C	FDA UDI	Class I	Active
Cd47 [epr21794]	ACI3284A	FDA UDI	Class I	Active
MYB (6q23) Orange	HFA7283A	FDA UDI	Class I	Active
Trbc1	OPAI3280T60	FDA UDI	Class I	Active
Moc-31	NPAI403T40	FDA UDI	Class I	Active
Smad4 [ep618y]	API3242AA	FDA UDI	Class I	Active
Sall4	AVI384G	FDA UDI	Class I	Active
Lmo2 [sp51]	API3262AA	FDA UDI	Class I	Active
Cd7	CM158CK	FDA UDI	Class I	Active
Hmb45	OPAI057T60	FDA UDI	Class I	Active
Ctla-4 [cal49]	ACI3220B	FDA UDI	Class I	Active
Helicobacter pylori	PM383L	FDA UDI	Class I	Active
Ck Lmw 8/18	PM056H	FDA UDI	Class I	Active
Tyrosinase	CM155A	FDA UDI	Class I	Active
Ki-67 + pHH3	API3198DSAA	FDA UDI	Class I	Active
Chamber Cleaning Kit	OPRI6031KC8	FDA UDI	Class I	Active
HER2/neu [IHC042]	AVA3274G	FDA UDI	Class I	Active
MART-1 + Tyrosinase + SOX10	API3165AA	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF)	CM423BK	FDA UDI	Class I	Active
Progesterone Receptor (PR) [SP2]	APA302AA	FDA UDI	Class II	Active
Msh2	OPAI219T60	FDA UDI	Class I	Active
MACH 3 Mouse HRP Polymer Detection	M3M530L	EUDAMEDFDA UDI	Class I	Active
MACH 4 Universal AP-Polymer Kit	M4U536H	EUDAMEDFDA UDI	Class I	Active
pHH3 (RM)	API3130AA	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

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.