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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 32 of 36

Device	Model / Reference	Registries	Class	Status
Cd103 (rm)	ACI3117G3	FDA UDI	Class I	Active
Stag1	API3250AA	FDA UDI	Class I	Active
Ctla-4 [cal49]	API3220AA	FDA UDI	Class I	Active
Background Punisher	BP974L	EUDAMEDFDA UDI	Class I	Active
intelliPATH FLX™ Peroxidase Blocking Reagent	IPB5000G20	EUDAMEDFDA UDI	Class I	Active
Fluorescence Antibody Diluent	FAD901L	EUDAMEDFDA UDI	Class I	Active
Glypican-3	CM396A	FDA UDI	Class I	Active
ISH Retrieval (AR3)	OPRI6021T60	FDA UDI	Class I	Active
Cd8 [c8/1779r]	API3219AA	FDA UDI	Class I	Active
Msa	CM079A	FDA UDI	Class I	Active
Cytokeratin 5 (CK5)	PME430AA	FDA UDI	Class I	Active
Cd21	PM142AA	FDA UDI	Class I	Active
Bcl-2	IP003G10	FDA UDI	Class I	Active
Dog1	CM385A	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	ACI3237A	FDA UDI	Class I	Active
Cd20 [l26]	PM004AA	FDA UDI	Class I	Active
Tia-1	PM130AA	EUDAMEDFDA UDI	Class I	Active
Prostate Cocktail (CK5 + CK14 + p63)	AVI3206G	FDA UDI	Class I	Active
Mum-1	NPAI352T40	FDA UDI	Class I	Active
ATM (11q22.3) Aqua	PFA7263V	FDA UDI	Class I	Active
Cd3	CME324A	FDA UDI	Class I	Active
Arginase-1	ACI3058B	FDA UDI	Class I	Active
ROR gamma T	ACI3208B	FDA UDI	Class I	Active
Melanoma Cocktail	VP078G	FDA UDI	Class I	Active
P504s-2x	PP365AA	FDA UDI	Class I	Active
Cd34	CM084A	FDA UDI	Class I	Active
HPV Type 6 Probe (Digoxigenin)	BPA4045T60	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF)	PM423H	FDA UDI	Class I	Active
PSAP [rACPP/1338]	AVI3263G	FDA UDI	Class I	Active
Cdx2 (m) + Cdh17 (rm)	API3135DSAA	FDA UDI	Class I	Active
Ki-67 [MIB-1]	NPAI3156T40	FDA UDI	Class I	Active
intelliPATH FLX™ DAB Chromogen Kit	IPK5010G80	EUDAMEDFDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	NPAI3237T40	FDA UDI	Class I	Active
Amacr (rm)	AVA3024G	FDA UDI	Class I	Active
CD45RO [UCHL-1] BSA Free (1.0mg/ml)	ACC006CFW	FDA UDI	Class I	Active
Mucin 5AC	CM231A	FDA UDI	Class I	Active
Cd71	ACI3110A	FDA UDI	Class I	Active
Npm1	ALI3281G7	FDA UDI	Class I	Active
Cyclin D1	CRM307CK	FDA UDI	Class I	Active
P27 Kip1 [y236]	AVI3282G	FDA UDI	Class I	Active
Cytokeratin 18 (CK18)	API3061AA	FDA UDI	Class I	Active
ATM (11q22.3) Green	HFA7316A	FDA UDI	Class I	Active
Tacha's Bluing Solution	HTBLU-M	FDA UDI	Class I	Active
TTF-1 + Napsin A	PPM394DSAA	FDA UDI	Class I	Active
Cd103 (rm)	API3117AA	FDA UDI	Class I	Active
p63	IP163G10	FDA UDI	Class I	Active
Cytokeratin 5/6 (CK 5/6)	IPI105G10	FDA UDI	Class I	Active
HPV Type 11 Probe (Digoxigenin)	BRA4046A	FDA UDI	Class I	Active
Npm1	OPAI3281T60	FDA UDI	Class I	Active
Ck5	CM234C	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.