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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 35 of 36

Device	Model / Reference	Registries	Class	Status
Cd5 (m)	CM099A	FDA UDI	Class I	Active
CD138 + Cyclin D1	API3193DSAA	FDA UDI	Class II	Active
P504s (p)	ACA200B	FDA UDI	Class I	Active
NeoPATH Pro Multiplex Detection 2 Kit	NPRI10072KT135	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	NPAA3291T80	FDA UDI	Class I	Active
V-Blocker	BRI4001H	FDA UDI	Class I	Active
HPV Type 51 Probe (Digoxigenin)	BRA4052-0.6	FDA UDI	Class I	Active
MACH 2 Rabbit HRP-Polymer	RHRP520L	EUDAMEDFDA UDI	Class I	Active
Pan CK [Lu-5]	PM043AA	FDA UDI	Class I	Active
Ttf-1	ALI087G7	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	IP062G10	FDA UDI	Class I	Active
Cdx2	VP226G	FDA UDI	Class I	Active
intelliPATH MAX	IPMX0001US-R	FDA UDI	Class I	Active
Cd44	CM318A	FDA UDI	Class I	Active
Factor VIII	CP039A	FDA UDI	Class I	Active
CD3 T-Cell	NPAI110T40	FDA UDI	Class I	Active
Cd56	CM164C	FDA UDI	Class I	Active
Gata-3	NPAI405T40	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	CM165C	FDA UDI	Class I	Active
Pax8 (m)	API438AA	FDA UDI	Class I	Active
Plap	PRM350AA	FDA UDI	Class I	Active
Deep Space Black™ Chromogen Kit	BRI4015L	FDA UDI	Class I	Active
p120 Catenin	ACI3008A	FDA UDI	Class I	Active
CAT Hematoxylin	CATHE-GL	EUDAMEDFDA UDI	Class I	Active
Myogenin	CM115A	FDA UDI	Class I	Active
Melan A (M)	NPAI3114T40	FDA UDI	Class I	Active
Antigen Retrieval 2 (AR2), low pH	OPRI6005T60	EUDAMEDFDA UDI	Class I	Active
Smad4 [ep618y]	ACI3242A	FDA UDI	Class I	Active
ONCORE Pro ISH Dewax Kit	OPRI6020KT60	FDA UDI	Class I	Active
Napsin A	AVI388G	FDA UDI	Class I	Active
Cd137	ACI3201A	FDA UDI	Class I	Active
Cmv	ACA118B	FDA UDI	Class I	Active
Fluoro Care Anti-Fade Mountant	FP001G5	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (HSA)	PM166AA	FDA UDI	Class I	Active
Hla-Dr [tal 1b5]	AVI3273G	FDA UDI	Class I	Active
Moc-31	CM403A	FDA UDI	Class I	Active
Nkx3.1 [d2y1a]	OPAI3260T60	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	NPAA301T80	FDA UDI	Class I	Active
Pan TRK [RM423]	ACI3267A	FDA UDI	Class I	Active
Hla-B [bc43]	ACI3289A	FDA UDI	Class I	Active
p16 + Ki-67	API3246DSH	FDA UDI	Class I	Active
Ki-67	CRM325B	FDA UDI	Class I	Active
ONCORE Pro Hematoxylin	OPRI6087T60	EUDAMEDFDA UDI	Class I	Active
HER2/neu [IHC042]	OPAA3274T60	FDA UDI	Class I	Active
Prame [epr20330]	ACI3252A	EUDAMEDFDA UDI	Class I	Active
Vimentin	CRM312B	FDA UDI	Class I	Active
Cd43	CM005C	FDA UDI	Class I	Active
Igf-1r	CM414A	FDA UDI	Class I	Active
MYC (8q24) Green	PFA7322V	FDA UDI	Class I	Active
Sox2	API3109AA	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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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.