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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 27 of 36

Device	Model / Reference	Registries	Class	Status
Collagen IV	CM112B	FDA UDI	Class I	Active
Ttf-1 [spt24]	ACI3126A	FDA UDI	Class I	Active
Prostate Cocktail-2X (CK5 + CK14 + p63)	IP364G10	FDA UDI	Class I	Active
Ck19	CM242C	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	CM165B	FDA UDI	Class I	Active
intelliPrep Solution	IPA5018G20	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	ACA301C	FDA UDI	Class I	Active
Copy Control 10 Green	PFA7200V	FDA UDI	Class I	Active
Sox10 (m)	API3099G25	FDA UDI	Class I	Active
Cytokeratin 5 (CK5)	CME430B	FDA UDI	Class I	Active
Insm1 [blr272l]	ALI3299G7	FDA UDI	Class I	Active
CK5 + p63	OPAI235T60	FDA UDI	Class I	Active
MACH 3 Mouse AP Polymer Detection	M3M532L	EUDAMEDFDA UDI	Class I	Active
CD30 (Ki-1)	IP031G10	FDA UDI	Class I	Active
Napsin A (RM)	API3043AA	FDA UDI	Class I	Active
Insm1 [blr272l]	ACI3299C	FDA UDI	Class I	Active
Cd247 [bl-336-1b2]	ACI3268C	FDA UDI	Class I	Active
Antigen Decloaker 10X	CB910M	EUDAMEDFDA UDI	Class I	Active
Cox-2	CRM306A	FDA UDI	Class I	Active
B72.3	PM002AA	FDA UDI	Class I	Active
4+ Biotinylated Goat Anti-Mouse IgG	GM601H	EUDAMEDFDA UDI	Class I	Active
p53	CME298AK	FDA UDI	Class I	Active
Hla-Dr [tal 1b5]	ACI3273A	FDA UDI	Class I	Active
4+ Streptavidin HRP Label	HP604H	EUDAMEDFDA UDI	Class I	Active
Cd163	CM353CK	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	ACI3237C	FDA UDI	Class I	Active
Cd3	AVI324G	FDA UDI	Class I	Active
Cyclin D1	OPAI307T60	FDA UDI	Class I	Active
Cyclin D1	PRM307AA	FDA UDI	Class I	Active
SSC Wash Buffer	OPRI4039T60	FDA UDI	Class I	Active
Vimentin	IP048G10	FDA UDI	Class I	Active
Background Sniper	BS966M	EUDAMEDFDA UDI	Class I	Active
p16 INK4a [BC42]	NPAI3231T40	FDA UDI	Class I	Active
Insm1 [blr272l]	NPAI3299T40	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF)	AVI423G	FDA UDI	Class I	Active
Msh6 [bc19]	ACI3215A	FDA UDI	Class I	Active
Ox40/Cd134	AVI3245G	FDA UDI	Class I	Active
Reveal Decloaker 10X	RV1000M	FDA UDI	Class I	Active
p63	CM163B	FDA UDI	Class I	Active
PSAP [rACPP/1338]	ALI3263G7	FDA UDI	Class I	Active
Cytokeratin 7 (CK7)	OPAI061T60	FDA UDI	Class I	Active
Dewax Solution 2, DS2 Kit	OPRI6003KT60	FDA UDI	Class I	Active
Erg	ALI421G7	FDA UDI	Class I	Active
Cyclin D1	OPAI432T60	FDA UDI	Class I	Active
Pax8 (m)	ACI438B	FDA UDI	Class I	Active
Synaptophysin	NPAI371T40	FDA UDI	Class I	Active
ONCORE Pro ISH HRP Detection	OPRI6047KT60	FDA UDI	Class I	Active
4+ Universal AP Detection	AP506US	EUDAMEDFDA UDI	Class I	Active
Granzyme B	API3202AA	FDA UDI	Class I	Active
Ck17	PM176AA	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.