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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 33 of 36

Device	Model / Reference	Registries	Class	Status
Cd31 (pecam-1)	CM131C	FDA UDI	Class I	Active
Glucagon	ALI3276G7	FDA UDI	Class I	Active
Synaptophysin	ALI371G7	FDA UDI	Class I	Active
MART-1 Cocktail	IP077G10	FDA UDI	Class I	Active
Smooth Muscle Myosin Heavy Chain	CM420A	FDA UDI	Class I	Active
E-cadherin	CM170C	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	OPAA135T60	FDA UDI	Class I	Active
Inhibin, Alpha	CM171C	FDA UDI	Class I	Active
Copy Control 10 Green	HFA7200A	FDA UDI	Class I	Active
NeoPATH Pro-Tect HRP Detection Kit	NPRI10031T135	FDA UDI	Class I	Active
Pax8 (m)	ALI438G7	FDA UDI	Class I	Active
Cea (m)	CM058C	FDA UDI	Class I	Active
Npm1	ACI3281A	FDA UDI	Class I	Active
p53 Tumor Suppressor Protein (M)	PM042AA	FDA UDI	Class I	Active
Universal Negative Control Serum	NC498L	EUDAMEDFDA UDI	Class I	Active
MART-1 Cocktail	CM077A	FDA UDI	Class I	Active
Decloaking Chamber™ NxGen Reconditioned	DC2012-220V-R	FDA UDI	Class I	Active
Desmin	CM036B	FDA UDI	Class I	Active
Ki-67	NPAI325T80	FDA UDI	Class I	Active
NeoPATH Pro Universal Negative Control Serum	NPRI10028T40	FDA UDI	Class I	Active
Peroxidazed 1	PX968M	EUDAMEDFDA UDI	Class I	Active
Sox11 (m)	AVI3120G	FDA UDI	Class I	Active
Gitr [cal8]	ACI3221A	FDA UDI	Class I	Active
P504s (p)	AVA200G	FDA UDI	Class I	Active
D13S319 (13q14.2) Orange	HFA7267A	FDA UDI	Class I	Active
Ki-67 [MIB-1]	API3156H	FDA UDI	Class I	Active
Diva Decloaker 100X	BRI2006L	FDA UDI	Class I	Active
Mcm2 + Top2a	NPAI3181T80	FDA UDI	Class I	Active
Cd3 [ln10]	NPAI3152T40	FDA UDI	Class I	Active
Pax5	CM207B	FDA UDI	Class I	Active
Uroplakin II + Uroplakin III	API3094AA	FDA UDI	Class I	Active
Cyclin D1	PME432AA	FDA UDI	Class I	Active
Glycophorin A [JC159]	OPAI3272T60	FDA UDI	Class I	Active
Polymer Negative Control Serum (Mouse & Rabbit)	NC499AA	FDA UDI	Class I	Active
Cd31 (pecam-1)	PM347AA	FDA UDI	Class I	Active
CD1a [O10]	API3158AA	FDA UDI	Class I	Active
Melanoma Cocktail	PM078AA	FDA UDI	Class I	Active
Cdx2 [bc39]	API3184AA	FDA UDI	Class I	Active
Romulin AEC Chromogen Kit	RAEC810L	FDA UDI	Class I	Active
Desmoglein 3 + CK5	ACI3018A	FDA UDI	Class I	Active
Progesterone Receptor (PR) [SP2]	ACA302A	FDA UDI	Class I	Active
Pan TRK [RM423]	ACI3267C	FDA UDI	Class I	Active
Pax8 (m)	ACI438A	FDA UDI	Class I	Active
Uroplakin II	NPAI3051T80	FDA UDI	Class I	Active
CD79a	CM067C	FDA UDI	Class I	Active
LCA Cocktail	PM016AA	FDA UDI	Class I	Active
PBS Plus 10X	PBS940M	EUDAMEDFDA UDI	Class I	Active
Cd7	CM158BK	FDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	NPAI001T80	FDA UDI	Class I	Active
p40 (P)	NPAI3030T40	FDA 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.