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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 7 of 36

Device	Model / Reference	Registries	Class	Status
Cdx2	IP226G10	FDA UDI	Class I	Active
Cyclin D1	CME432C	FDA UDI	Class I	Active
Bap1	API3247AA	FDA UDI	Class I	Active
Reveal Decloaker RTU	RV1000G1	FDA UDI	Class I	Active
Ox40/Cd134	API3245AA	FDA UDI	Class I	Active
4+ Biotinylated Goat Anti-Rabbit IgG (Ms, Rt) Ads	GR608H	EUDAMEDFDA UDI	Class I	Active
p63	CM163A	FDA UDI	Class I	Active
ARC – Antigen Retrieval Chamber	DCARC0001-R	FDA UDI	Class I	Active
Satb2 [cl0323]	ACI3259A	FDA UDI	Class I	Active
Melan A	OPAI3114T60	FDA UDI	Class I	Active
Cd68 [kp1]	ALI033G7	FDA UDI	Class I	Active
Glucagon	OPAI3276T60	FDA UDI	Class I	Active
Cd3 [ln10]	ACI3152C	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	OPAI3277T60	FDA UDI	Class I	Active
Erg-2 (erg + Ck5)	API437DSAA	FDA UDI	Class I	Active
p63	OPAI163T60	FDA UDI	Class I	Active
Cd8 [c8/144b]	ALI3160G7	FDA UDI	Class I	Active
Cd54 [e3q9n]	ACI3296C	FDA UDI	Class I	Active
Tigit (rm) [blr047f]	ACI3243A	FDA UDI	Class I	Active
Cytokeratin LMW (8/18)	NPAI056T80	FDA UDI	Class I	Active
HPV Type 51 Probe (Digoxigenin)	BRA4052A	FDA UDI	Class I	Active
Egfr	CM063AK	FDA UDI	Class I	Active
Cd99	OPAI392T60	FDA UDI	Class I	Active
MART-1 Cocktail	OPAI077T60	FDA UDI	Class I	Active
p16 INK4a [BC42]	AVI3231G25	FDA UDI	Class I	Active
CD117/c-kit	CME296CK	FDA UDI	Class I	Active
Cd137 [blr051f]	API3264AA	FDA UDI	Class I	Active
Smooth Muscle Myosin Heavy Chain	PM420AA	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	AVI3278G	FDA UDI	Class I	Active
p27 KIP1 [Y236]	ALI3282G7	FDA UDI	Class I	Active
CD3 T-Cell (M)	ALI110G7	FDA UDI	Class I	Active
Stag1	ALI3250G7	FDA UDI	Class I	Active
Melan A (M)	NPAI3114T80	FDA UDI	Class I	Active
Prostein	ACI3163B	FDA UDI	Class I	Active
Ki-67 + Caspase-3	PPM240DSAA	FDA UDI	Class I	Active
TERC (3q26.2) Red	PFA7305V	FDA UDI	Class I	Active
Renoir Red Diluent	PD904M	EUDAMEDFDA UDI	Class I	Active
HPV Type 16 Probe (Digoxigenin)	BRA4047A	FDA UDI	Class I	Active
Desmoglein 3	NPAI419T40	FDA UDI	Class I	Active
Peroxidazed 1	PX968MM	FDA UDI	Class I	Active
Inhibin, Alpha	PM171AA	FDA UDI	Class I	Active
Progesterone Receptor (PR) [16]	ACA424C	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	ALI3278G7	FDA UDI	Class I	Active
Cd39 [epr20627]	OPAI3283T60	FDA UDI	Class I	Active
Foxp3 [86d]	API3197AA	FDA UDI	Class I	Active
Cd5 (m)	PM099AA	FDA UDI	Class I	Active
Cyclin D1	CRM307AK	FDA UDI	Class I	Active
Zap-70 (lr)	ACI259A	FDA UDI	Class I	Active
Ber-EP4	NPAI107T40	FDA UDI	Class I	Active
Ttf-1 [spt24]	NPAI3126T40	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

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.