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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 24 of 36

Device	Model / Reference	Registries	Class	Status
CDKN2A (9p21.3) Orange	PFA7264V	FDA UDI	Class I	Active
Cdx2	PM226H	FDA UDI	Class I	Active
Mlh-1 [bc23]	ACI3214C	FDA UDI	Class I	Active
Cmv	APA118AA	FDA UDI	Class I	Active
Ttf-1 [spt24]	AVI3126G	FDA UDI	Class I	Active
Cd54 [e3q9n]	OPAI3296T60	FDA UDI	Class I	Active
c-Myc	CME415AK	FDA UDI	Class I	Active
CD68 [KP1] BSA Free (1.0mg/ml)	ACC033CFW	FDA UDI	Class I	Active
Gfap (m)	CM065A	FDA UDI	Class I	Active
Smoothelin	PM372AA	FDA UDI	Class I	Active
CD79a	PM067AA	FDA UDI	Class I	Active
Ttf-1 [spt24]	ACI3126C	FDA UDI	Class I	Active
Estrogen Receptor (ER) [6F11 + SP1]	API308AA	FDA UDI	Class II	Active
Egfr	CM063CK	FDA UDI	Class I	Active
Cd47 [epr21794]	ACI3284C	FDA UDI	Class I	Active
Mart-1 + Tyrosinase + SOX10	AVI3216G	FDA UDI	Class I	Active
5p15.2 Green	PFA7250V	FDA UDI	Class I	Active
Cd7	PM158AA	FDA UDI	Class I	Active
Ctla-4	ACI3211B	FDA UDI	Class I	Active
Ki-67	CRM325A	FDA UDI	Class I	Active
Foxp3	API3164AA	FDA UDI	Class I	Active
Pan Melanoma + Ki-67	OPAI362T60	FDA UDI	Class I	Active
hCG (Beta)	CP124A	FDA UDI	Class I	Active
Dog1	PM385AA	FDA UDI	Class I	Active
Van Gogh Yellow Diluent	PD902L	EUDAMEDFDA UDI	Class I	Active
Prostate Specific Antigen (PSA)	CME390CK	FDA UDI	Class I	Active
Adipophilin	ACI3138A	FDA UDI	Class I	Active
Cd39 [epr20627]	ALI3283G7	FDA UDI	Class I	Active
Monet Blue Diluent	PD901H	EUDAMEDFDA UDI	Class I	Active
p63	ALI163G7	FDA UDI	Class I	Active
Hhv-8 [13b10]	ALA3290G7	FDA UDI	Class I	Active
Napsin A	AVI434G	FDA UDI	Class I	Active
DAB Chromogen	OPRI6054T60	FDA UDI	Class I	Active
Tia-1	AVI130G	FDA UDI	Class I	Active
Ttf-1 + Ck5	PM425DSAA	FDA UDI	Class I	Active
Cd33	API3116AA	FDA UDI	Class I	Active
Spirochete	ACI135A	FDA UDI	N	Active
Vimentin	CRM312A	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ACI3278A	FDA UDI	Class I	Active
CK5/14 + p63 + P504S	OPAI225DST60	FDA UDI	Class I	Active
Gitr [cal8]	API3221AA	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	PM165H	FDA UDI	Class I	Active
Gfap (p)	PP040AA	FDA UDI	Class I	Active
IgG4 (M)	ACI3115B	FDA UDI	Class I	Active
Copy Control 3 Aqua	CFA7164Y	FDA UDI	Class I	Active
Cytokeratin 5/6 (CK5/6)	ALI105G7	FDA UDI	Class I	Active
CAT Hematoxylin	CATHE-M	EUDAMEDFDA UDI	Class I	Active
Foxp3 [86d]	ACI3197C	FDA UDI	Class I	Active
TBS Auto Wash Buffer 40X	TWB946L2J	EUDAMEDFDA UDI	Class I	Active
Cd5 (m)	NPAI099T40	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.