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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 25 of 36

Device	Model / Reference	Registries	Class	Status
MACH 1 Universal HRP-Polymer Kit	M1U539L10	EUDAMEDFDA UDI	Class I	Active
MACH 3 Rabbit HRP Polymer Detection	M3R531G	FDA UDI	Class I	Active
P504s-2x	PP365H	FDA UDI	Class I	Active
Erg	PM421AA	FDA UDI	Class I	Active
Factor XIIIa	PM357AA	FDA UDI	Class I	Active
Ttf-1 [spt24]	ALI3126G7	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	OPAI3278T60	FDA UDI	Class I	Active
Pan Melanoma Cocktail-2	PM178AA	FDA UDI	Class I	Active
IgG4 (M)	API3115AA	FDA UDI	Class I	Active
I.E.D. Unit (Ion-Exchange Decal Unit)	IED1204	FDA UDI	Class I	Active
Ck Lmw 8/18	PM056AA	FDA UDI	Class I	Active
Desmin	PM036AA	FDA UDI	Class I	Active
Cd34	IP084G10	FDA UDI	Class I	Active
LAMP1 (13q34) Green	HFA7281A	FDA UDI	Class I	Active
RISH™ RNA Positive Control Probe	OPPA4028T60	FDA UDI	Class I	Active
Hhv-8 [13b10]	ACA3290C	FDA UDI	Class I	Active
p40 (M) [BC28]	NPAI3066T80	FDA UDI	Class I	Active
Hla-B [bc43]	AVI3289G	FDA UDI	Class I	Active
CD30 Cocktail	PM074AA	FDA UDI	Class I	Active
Vimentin	PRM312AA	FDA UDI	Class I	Active
Cd3 [bc33]	ACI3170C	FDA UDI	Class I	Active
Epidermal Growth Factor Receptor (EGFR)	ACI063CK	FDA UDI	Class I	Active
Ttf-1	CM087C	FDA UDI	Class I	Active
Cd3	PME324AA	FDA UDI	Class I	Active
Cmv	ACA118A	FDA UDI	Class I	Active
Msh6	IPI265G10	FDA UDI	Class I	Active
CK5/14 + p63 + CK7/18	VP360DSKG25	FDA UDI	Class I	Active
HPV Type 18 Probe (Digoxigenin)	BRA4048-0.6	FDA UDI	Class I	Active
Cd10	AVI129G	FDA UDI	Class I	Active
Msh6	CM265BK	FDA UDI	Class I	Active
Ck14	CM185C	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	AVR3278G	FDA UDI	Class I	Active
Vista [blr035f]	ACI3271A	FDA UDI	Class I	Active
Thyroglobulin Cocktail	IP022G10	FDA UDI	Class I	Active
Renoir Red Diluent	PD904H	EUDAMEDFDA UDI	Class I	Active
Cdx2 (rm)	ACI3144A	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ACR3278A	FDA UDI	Class I	Active
Bcl-6 [LN22]	ALI410G7	FDA UDI	Class I	Active
Uroplakin III	API3023AA	FDA UDI	Class I	Active
Gata-3	PM405H	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	VP011G	FDA UDI	Class I	Active
Cd57	CM007C	FDA UDI	Class I	Active
Tle 1 [epr9386(2)]	API3301AA	FDA UDI	Class I	Active
c-Myc	OPAI415T60	FDA UDI	Class I	Active
Polymer Negative Control Serum (Mouse & Rabbit)	NC499L	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	NPAA3291T40	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF)	PM423AA	FDA UDI	Class I	Active
Desmoglein 3 + CK5	ACI3018C	FDA UDI	Class I	Active
Romulin AEC Chromogen Kit	RAEC810M	FDA UDI	Class I	Active
intelliPATH Plus	IPPLS0001INTL	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.