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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 15 of 36

Device	Model / Reference	Registries	Class	Status
Diva Decloaker RTU	DV2004G1	FDA UDI	Class I	Active
Microglia (Iba1)	CP290A	FDA UDI	Class I	Active
Multiplex Detection 1	OPRI6061T60	FDA UDI	Class I	Active
Napsin A	NPAI388T80	FDA UDI	Class I	Active
Msh6	NPAI265T40	FDA UDI	Class I	Active
Hla-Dr [tal 1b5]	OPAI3273T60	FDA UDI	Class I	Active
Cd20 [l26]	IP004G10	FDA UDI	Class I	Active
Ae1/Ae3 + 8/18	PM162H	FDA UDI	Class I	Active
Desmoglein 3 + CK5	API3018AA	FDA UDI	Class I	Active
Ck7	CM061B	FDA UDI	Class I	Active
Tigit [bc41]	API3254AA	FDA UDI	Class I	Active
4+ Streptavidin HRP Label	HP604L	EUDAMEDFDA UDI	Class I	Active
MACH 4 Universal AP-Polymer Kit	M4U536G	EUDAMEDFDA UDI	Class I	Active
Ck7	CRM339A	FDA UDI	Class I	Active
MACH 3 Rabbit AP Polymer Detection	M3R533H	EUDAMEDFDA UDI	Class I	Active
Gcdfp-15	CM113A	FDA UDI	Class I	Active
SSC Wash buffer	BRI4039MM	FDA UDI	Class I	Active
Bcl-2	OPAI003T60	FDA UDI	Class I	Active
Hla-B [bc43]	OPAI3289T60	FDA UDI	Class I	Active
Mlh-1 [bc23]	AVI3214G	FDA UDI	Class I	Active
CK5/14 + p63 + CK7/18	PM360DSH	FDA UDI	Class I	Active
Copy Control 4q12 Aqua	HFA7169A	FDA UDI	Class I	Active
Msa	CM079B	FDA UDI	Class I	Active
HPV Type 31 Probe (Digoxigenin)	BPA4051T60	FDA UDI	Class I	Active
4+ Streptavidin AP Label	AP605H	FDA UDI	Class I	Active
Cd4 [4b12]	ACI3148C	FDA UDI	Class I	Active
Uroplakin II	ACI3051A	FDA UDI	Class I	Active
P504s (p)	APA200AA	FDA UDI	Class I	Active
Tacha's Automated Hematoxylin	NM-HEM-M	EUDAMEDFDA UDI	Class I	Active
Calretinin	IP092G10	FDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	ALI001G7	FDA UDI	Class I	Active
MACH 2 Mouse AP-Polymer	MALP521G	EUDAMEDFDA UDI	Class I	Active
Mammaglobin (M)	PM269H	FDA UDI	Class I	Active
P504s (p)	NPAA200T80	FDA UDI	Class I	Active
Helicobacter pylori	OPAI383T60	FDA UDI	Class I	Active
Pms2	ALI344G7	FDA UDI	Class I	Active
Cd7	CM158AK	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ACI3278C	FDA UDI	Class I	Active
Cd21	CM142C	FDA UDI	Class I	Active
Cd3 [ln10]	API3152H	FDA UDI	Class I	Active
Ox40/Cd134	ALI3245G7	FDA UDI	Class I	Active
Tia-1	ALI130G7	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	ALA054G7	FDA UDI	Class I	Active
Pd-1 [cal20]	ACI3224A	FDA UDI	Class I	Active
Melan A (M)	ACI3114A	FDA UDI	Class I	Active
Desmoglein 3	CM419A	FDA UDI	Class I	Active
Cytokeratin 7 (CK7)	ALI061G7	FDA UDI	Class I	Active
Melan A (M)	AVI3114G	FDA UDI	Class I	Active
Sall4	CM384C	FDA UDI	Class I	Active
p16 INK4a [BC42]	ACI3231C	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.