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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 4 of 36

Device	Model / Reference	Registries	Class	Status
Prostate Cocktail-2X (CK5 + CK14 + p63)	PM364JJK	FDA UDI	Class I	Active
Hmb45	PM057AA	FDA UDI	Class I	Active
Tia-1	CM130B	FDA UDI	Class I	Active
MACH 2 Rabbit AP-Polymer	RALP525G	EUDAMEDFDA UDI	Class I	Active
Sma	CM001A	FDA UDI	Class I	Active
Tle 1 [epr9386(2)]	ACI3301C	FDA UDI	Class I	Active
Tigit (rm) [blr047f]	API3243AA	FDA UDI	Class I	Active
Glucagon	AVI3276G	FDA UDI	Class I	Active
CK5 + p63	NPAI235T40	FDA UDI	Class I	Active
Moc-31	PM403AA	FDA UDI	Class I	Active
Helicobacter pylori	ALA383G7	FDA UDI	Class I	Active
Copy Control 12 Aqua	PFA7211V	FDA UDI	Class I	Active
Myogenin	PM115AA	FDA UDI	Class I	Active
Amacr (rm)	ALA3024G7	FDA UDI	Class I	Active
Cytokeratin HMW	NPAI127T80	FDA UDI	Class I	Active
HPV Type 31 Probe (Digoxigenin)	BRA4051-0.6	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	APA3291H	FDA UDI	Class I	Active
Napsin A	PP434AA	FDA UDI	Class I	Active
Granzyme B	ACI3202B	FDA UDI	Class I	Active
Androgen Receptor	API109AA	FDA UDI	Class I	Active
Cd68 [kp1]	CM033B	FDA UDI	Class I	Active
CD3 T-Cell (M)	VP110G	FDA UDI	Class I	Active
Moc-31	AVI403G	FDA UDI	Class I	Active
Ercc1	ACI3147B	FDA UDI	Class I	Active
Progesterone Receptor (PR) [16]	ACI424C	FDA UDI	Class I	Active
Background Terminator	BT967H	FDA UDI	Class I	Active
Cd33	ACI3116A	FDA UDI	Class I	Active
MACH 3 Mouse AP Polymer Detection	M3M532G	FDA UDI	Class I	Active
NeoPath Background Punisher	NPRI10029T40	FDA UDI	Class I	Active
Denaturing Solution Kit	DNS001L	FDA UDI	Class I	Active
Sox2	ACI3109A	FDA UDI	Class I	Active
MACH 4 Universal AP Polymer Kit	M4U536G20	EUDAMEDFDA UDI	Class I	Active
Cd3 (p)	PP215AA	FDA UDI	Class I	Active
P504s (p)	ACA200A	FDA UDI	Class I	Active
Cyclin D1	NPAI307T40	FDA UDI	Class I	Active
Cd20 [l26]	CM004A	FDA UDI	Class I	Active
CAT Hematoxylin	CATHE-MM	EUDAMEDFDA UDI	Class I	Active
Cytokeratin 5/14 Cocktail	ACI3025C	FDA UDI	Class I	Active
CD30 (Ki-1)	CM346A	FDA UDI	Class I	Active
Van Gogh Diluent	PD902M	EUDAMEDFDA UDI	Class I	Active
Bob-1	CM418B	FDA UDI	Class I	Active
Rubens Eosin-Phloxine	HTEP-GL	FDA UDI	Class I	Active
Gata-3	PM405AA	FDA UDI	Class I	Active
E-cadherin	ALI170G7	FDA UDI	Class I	Active
Pd-L1	ALI3171G7	FDA UDI	Class I	Active
intelliPATH™ Hematoxylin	IPCS5006G20	EUDAMEDFDA UDI	Class I	Active
Mlh-1 [bc23]	ACI3214A	FDA UDI	Class I	Active
Ck7	PM061AA	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	ACI3270A	FDA UDI	Class I	Active
Bcl-2	PM003AA	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.