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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 19 of 36

Device	Model / Reference	Registries	Class	Status
Msh2	AVI219G	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	ACI3277A	FDA UDI	Class I	Active
Tia-1	CM130A	FDA UDI	Class I	Active
RISH™ AP Detection Kit	RI0213KG	FDA UDI	Class I	Active
p40 (P)	ACI3030B	FDA UDI	Class I	Active
Uroplakin II	ALI3051G7	FDA UDI	Class I	Active
Ca-9	ACI3285A	FDA UDI	Class I	Active
Bob-1	PM418AA	FDA UDI	Class I	Active
p120 Catenin	ACI3008B	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3 + 8/18]	ACI3227A	FDA UDI	Class I	Active
Sall4	CM384A	FDA UDI	Class I	Active
Cytokeratin 5/14 Cocktail	ACI3025A	FDA UDI	Class I	Active
4+ Biotinylated Universal Goat Link	GU600L	EUDAMEDFDA UDI	Class I	Active
MACH 4 Universal HRP-Polymer	M4U534G80	FDA UDI	Class I	Active
GATA-3 + Uroplakin II	API3173AA	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	CM278AK	FDA UDI	Class I	Active
P504s (p)	ACA200C	FDA UDI	Class I	Active
Bcl-2	ALI003G7	FDA UDI	Class I	Active
Cd103 (rm)	ACI3117A	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	NPAI3277T40	FDA UDI	Class I	Active
Progesterone Receptor (PR) [PgR636]	APA343AA	FDA UDI	Class II	Active
Pax5	ALI207G7	FDA UDI	Class I	Active
p16 INK4a [BC42]	NPAI3231T80	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	NPAI3237T80	FDA UDI	Class I	Active
Helicobacter pylori	PM383H	FDA UDI	Class I	Active
Mammaglobin (M)	PM269AA	FDA UDI	Class I	Active
Atrx	API3251AA	FDA UDI	Class I	Active
D2-40 (Lymphatic Marker)	IP266G10	FDA UDI	Class I	Active
Cd3 (m)	PM110H	FDA UDI	Class I	Active
Cd3 (m)	CM110CK	FDA UDI	Class I	Active
P27 Kip1 [y236]	API3282AA	FDA UDI	Class I	Active
Tdt (P)	CP134CK	FDA UDI	Class I	Active
Ck19	PM242AA	FDA UDI	Class I	Active
Mouse Amp AP Detection	OPRI6088T60	EUDAMEDFDA UDI	Class I	Active
Cd57	PM007AA	FDA UDI	Class I	Active
Pd-1	API3137AA	FDA UDI	Class I	Active
TP53 (17p13) Orange	HFA7306A	FDA UDI	Class I	Active
Pax5	PM207AA	FDA UDI	Class I	Active
TTF-1 + Napsin A	IPI394DSG10	FDA UDI	Class I	Active
Ifng [ifng/3996r]	ACI3266C	FDA UDI	Class I	Active
Chromogranin A	CM010C	FDA UDI	Class I	Active
Ca-9	ALI3285G7	FDA UDI	Class I	Active
Cmv	ALA118G7	FDA UDI	Class I	Active
BCA-225 [Cu-18]	API3241AA	FDA UDI	Class I	Active
Breast Cocktail (CK HMW/p63 + CK7/8/18)	AVI3203DSKG	FDA UDI	Class I	Active
1p21.2 Green	HFA7307A	FDA UDI	Class I	Active
Carezyme III: Pronase Kit	PRT957KH	EUDAMEDFDA UDI	Class I	Active
Glucagon	ACI3276A	FDA UDI	Class I	Active
DAB Buffer	OPRI6055T60	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	ACI054C	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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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.