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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 18 of 36

Device	Model / Reference	Registries	Class	Status
Uroplakin II	API3051AA	FDA UDI	Class I	Active
CD30 (Ki-1)	CM346C	FDA UDI	Class I	Active
Copy Control 17 Aqua	HFA7226A	FDA UDI	Class I	Active
Galectin-3	ACI3174A	FDA UDI	Class I	Active
CD3 T-Cell	NPAI110T80	FDA UDI	Class I	Active
Napsin A	ALI388G7	FDA UDI	Class I	Active
Betazoid DAB Chromogen Kit	BDB2004MM	EUDAMEDFDA UDI	Class I	Active
Hmb45	ALI057G7	FDA UDI	Class I	Active
Ema [e29]	ACI3038A	FDA UDI	Class I	Active
Msh2	ALI219G7	FDA UDI	Class I	Active
Pan TRK [RM423]	OPAI3267T60	FDA UDI	Class I	Active
intelliPATH FLX Universal Negative Control	IP498G20	EUDAMEDFDA UDI	Class I	Active
Cd3 [ln10]	NPAI3152T80	FDA UDI	Class I	Active
CD79a	CM067A	FDA UDI	Class I	Active
Inhibin, Alpha	CM171A	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	PM278AA	FDA UDI	Class I	Active
Glutamine Synthetase	ACI3009A	FDA UDI	Class I	Active
Wash Buffer	OPRI6012MM	FDA UDI	Class I	Active
Pd-L1	OPAI3171T60	FDA UDI	Class I	Active
Sox11 (m)	ACI3120A	FDA UDI	Class I	Active
PeroxAbolish	PXA969L	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	API3154DSH	FDA UDI	Class I	Active
Ck20	PM062H	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	CM011C	FDA UDI	Class I	Active
Granzyme B	ACI3202A	FDA UDI	Class I	Active
Cmv	ACA118C	FDA UDI	Class I	Active
Cd31	PM131AA	FDA UDI	Class I	Active
Bob-1	CM418A	FDA UDI	Class I	Active
Cd137	ACI3201B	FDA UDI	Class I	Active
Pd-1 (rm)	API3162AA	FDA UDI	Class I	Active
Progesterone Receptor (PR) [SP2]	ACI302C	FDA UDI	Class I	Active
Msh6	CM265CK	FDA UDI	Class I	Active
Nkx3.1	CP422A	FDA UDI	Class I	Active
Cdx2	CM226B	FDA UDI	Class I	Active
P504s (p)	AVA200G25	FDA UDI	Class I	Active
Copy Control 12 Green	HFA7210A	FDA UDI	Class I	Active
Ki-67	PRM325H	FDA UDI	Class I	Active
Progesterone Receptor (PR) [16]	ACI424A	FDA UDI	Class I	Active
Smooth Muscle Myosin Heavy Chain	CM420B	FDA UDI	Class I	Active
Protease XXIV Kit	PR960KG15	EUDAMEDFDA UDI	Class I	Active
Renaissance Background Reducing Diluent	PD905H	EUDAMEDFDA UDI	Class I	Active
Cd8 [c8/144b]	ACI3160A	FDA UDI	Class I	Active
Prame [epr20330]	ALI3252G7	EUDAMEDFDA UDI	Class I	Active
Copy Control 7 Aqua	PFA7185V	FDA UDI	Class I	Active
Copy Control 7 Green	PFA7184V	FDA UDI	Class I	Active
E-cadherin	CM170A	FDA UDI	Class I	Active
Gata-3	ALI405G7	FDA UDI	Class I	Active
LAMP1 (13q34) Aqua	HFA7282A	FDA UDI	Class I	Active
Hmb45	CM057C	FDA UDI	Class I	Active
Universal Negative Control Serum	NC498MM	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.