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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 10 of 36

Device	Model / Reference	Registries	Class	Status
Pax8 (m)	ACI438C	FDA UDI	Class I	Active
Cd137	API3201AA	FDA UDI	Class I	Active
CD8 [C8/144B] BSA Free (1.0mg/ml)	ACC3160CFW	FDA UDI	Class I	Active
intelliPATH™ Hematoxylin	IPCS5006L	EUDAMEDFDA UDI	Class I	Active
Synaptophysin	OPAI371T60	FDA UDI	Class I	Active
Caspase-3 (Cleaved)	PP229AA	FDA UDI	Class I	Active
Ercc1	ACI3147A	FDA UDI	Class I	Active
Prostein	ACI3163A	FDA UDI	Class I	Active
CD117/c-kit	IP296G10	FDA UDI	Class I	Active
c-erbB-2/HER2	NPAA342T40	FDA UDI	Class I	Active
ONCORE Pro Warp Red Chromogen Kit	OPRI6083KT60	FDA UDI	Class I	Active
c-Myc	AVI415G	FDA UDI	Class I	Active
Betazoid DAB Substrate Buffer	DS900H	FDA UDI	Class I	Active
Cd10	CM129BK	FDA UDI	Class I	Active
Estrogen Receptor (ER) [6F11]	APA093AA	FDA UDI	Class II	Active
Cd43	PM005AA	FDA UDI	Class I	Active
RISH™ Cytomegalovirus (CMV) Probe	BRA0011T	FDA UDI	Class I	Active
Copy Control 7 Gold	CFA7188Y	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	ALI3277G7	FDA UDI	Class I	Active
Amyloid A	PM125AA	FDA UDI	Class I	Active
P504s (p)	ALA200G7	FDA UDI	Class I	Active
Cd3 [b33]	ALI3170G7	FDA UDI	Class I	Active
Prostate Cocktail-2X (CK5 + CK14 + p63)	PM364HK	FDA UDI	Class I	Active
Beta-Catenin	PM406AA	FDA UDI	Class I	Active
Cd23	PM100AA	FDA UDI	Class I	Active
Copy Control 6q11.1 Green	PFA7178V	FDA UDI	Class I	Active
Cytokeratin HMW [34BetaE12]	OPAI127T60	FDA UDI	Class I	Active
Cyclin D1	CRM307BK	FDA UDI	Class I	Active
Ros1 [epmghr2]	ACI3240B	FDA UDI	Class I	Active
Pax8	PP379AA	FDA UDI	Class I	Active
Cd71	API3110AA	FDA UDI	Class I	Active
CK5/14 + p63 + P504S	NPAI225DST80	FDA UDI	Class I	Active
Cd10	CM129AK	FDA UDI	Class I	Active
Alk [5a4]	ACI3041B	FDA UDI	Class I	Active
Betazoid DAB Chromogen Kit	BDB2004H	FDA UDI	Class I	Active
Cd20 [bc30]	OPAI3287T60	FDA UDI	Class I	Active
c-erbB-2/HER2	ACA342A	FDA UDI	Class I	Active
Pms2	NPAI344T40	FDA UDI	Class I	Active
DNA Hybridization Buffer	BRI4036G10	FDA UDI	Class I	Active
D2-40	CM266C	FDA UDI	Class I	Active
Bajoran Purple Chromogen Kit	BJP811L	FDA UDI	Class I	Active
Prostate Specific Antigen (PSA)	CME390AK	FDA UDI	Class I	Active
E-Cadherin [CDH1/2208R]	ACI3230A	FDA UDI	Class I	Active
MACH 2 Universal HRP Polymer Detection	M2U522MM	FDA UDI	Class I	Active
Prame [epr20330]	OPAI3252T60	EUDAMEDFDA UDI	Class I	Active
Caspase-3 (Cleaved)	CP229C	FDA UDI	Class I	Active
Cd138	NPAI167T40	FDA UDI	Class I	Active
Idh1 R132h [ihc132]	AVI3253G	FDA UDI	Class I	Active
Mlh-1	CM220AK	FDA UDI	Class I	Active
Ema [e29]	ACI3038C	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.