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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 3 of 36

Device	Model / Reference	Registries	Class	Status
Progesterone Receptor (PR) [SP2]	ACA302C	FDA UDI	Class I	Active
MART-1 + Tyrosinase + pHH3	API3186DSAA	FDA UDI	Class I	Active
Napsin A	CM388CK	FDA UDI	Class I	Active
Tigit (rm) [blr047f]	ACI3243C	FDA UDI	Class I	Active
MACH 4 Universal HRP Polymer	M4U534L	FDA UDI	Class I	Active
Cd10	PM129AA	FDA UDI	Class I	Active
Claudin-4	NPAI3121T40	FDA UDI	Class I	Active
p40 (M)	IPI3066G10	FDA UDI	Class I	Active
Ido1	API3210AA	FDA UDI	Class I	Active
Pan CK [Lu-5]	CM043C	FDA UDI	Class I	Active
Cd31 (pecam-1)	CM347C	FDA UDI	Class I	Active
Pcna [pc10]	ACI3255A	FDA UDI	Class I	Active
Factor XIIIa	ALI357G7	FDA UDI	Class I	Active
Idh1 R132h [ihc132]	ACI3253C	FDA UDI	Class I	Active
Bap1	ACI3247B	FDA UDI	Class I	Active
Synaptophysin	IP371G10	FDA UDI	Class I	Active
Smad4 [ep618y]	ACI3242B	FDA UDI	Class I	Active
Cox-2	PRM306AA	FDA UDI	Class I	Active
Tyrosinase	PM155AA	FDA UDI	Class I	Active
intelliPATH™ Multiplex Secondary Reagent 2	IPSC5004G80	FDA UDI	Class I	Active
Imp3 (rm)	ACI3180B	FDA UDI	Class I	Active
Cd138	AVI167G	FDA UDI	Class I	Active
Vulcan Fast Red Chromogen Kit 2	FR805M	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	ACA3291C	FDA UDI	Class I	Active
Cd39 [epr20627]	ACI3283A	FDA UDI	Class I	Active
Arginase-1	ACI3058A	FDA UDI	Class I	Active
P504s (p)	IPA200G10	FDA UDI	Class I	Active
Peroxidazed Diluent	PX970LH	EUDAMEDFDA UDI	Class I	Active
Cdx2 [bc39]	ACI3184A	FDA UDI	Class I	Active
p40 (P)	OPAI3030T60	FDA UDI	Class I	Active
Desmoglein 3 + p40 (M)	API3067AA	FDA UDI	Class I	Active
p40 (M)	API3066AA	FDA UDI	Class I	Active
p40 (P)	API3030AA	FDA UDI	Class I	Active
H3K27me3 [C36B11]	API3249AA	FDA UDI	Class I	Active
BCA-225 [Cu-18]	ACI3241B	FDA UDI	Class I	Active
intelliPATH FLX Automated Slide Staining System	IPS0001US	FDA UDI	Class I	Active
Mlh-1	CM220BK	FDA UDI	Class I	Active
p63-2X	PM366AAK	FDA UDI	Class I	Active
p53	ALI298G7	FDA UDI	Class I	Active
Cytokeratin 5 (CK5)	NPAI234T40	FDA UDI	Class I	Active
Cdx2	PM226AA	FDA UDI	Class I	Active
Epstein-Barr Virus (EBV)	APA111AA	FDA UDI	Class I	Active
Estrogen Receptor (ER) [6F11 + SP1]	APA308H	FDA UDI	Class II	Active
Phospho-Histone H3	CP404A	FDA UDI	Class I	Active
Cytokeratin 7 (CK7)	NPAI061T40	FDA UDI	Class I	Active
Copy Control 17 Green	HFA7225A	FDA UDI	Class I	Active
Prame [epr20330]	API3252G20	FDA UDI	Class I	Active
Ber-EP4	IP107G10	FDA UDI	Class I	Active
Erg	VP421G	FDA UDI	Class I	Active
Prostein	API3163AA	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.