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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 34 of 36

Device	Model / Reference	Registries	Class	Status
Glucagon	API3276AA	FDA UDI	Class I	Active
Tim3 [blr033f]	ACI3258C	FDA UDI	Class I	Active
Ox40/Cd134	ACI3245A	FDA UDI	Class I	Active
Cd31 (pecam-1)	NPAI347T40	FDA UDI	Class I	Active
CK5 + p63	NPAI235T80	FDA UDI	Class I	Active
Synaptophysin	PM371AA	FDA UDI	Class I	Active
Hhv-8 [13b10]	APA3290AA	FDA UDI	Class I	Active
Prostate Specific Antigen (PSA)	OPAI390T60	FDA UDI	Class I	Active
VP Monet Blue Diluent	VPD901L	FDA UDI	Class I	Active
Hmb45	IP057G10	FDA UDI	Class I	Active
Kappa Light Chain [L1C1]	ACI3149C	FDA UDI	Class I	Active
Ca-9	ACI3285C	FDA UDI	Class I	Active
Galectin-3	API3174AA	FDA UDI	Class I	Active
Cd19	CM310A	FDA UDI	Class I	Active
Calretinin	NPAI092T40	FDA UDI	Class I	Active
Bcl-6 [LN22]	AVI410G	FDA UDI	Class I	Active
Atrx	ACI3251A	FDA UDI	Class I	Active
Warp Red Chromogen Kit	WR806H	EUDAMEDFDA UDI	Class I	Active
MACH 2 Mouse HRP-Polymer	MHRP520MM	EUDAMEDFDA UDI	Class I	Active
Cd68 [kp1]	IP033G10	FDA UDI	Class I	Active
MART-1 Cocktail	NPAI077T40	FDA UDI	Class I	Active
Calretinin	CP092A	FDA UDI	Class I	Active
c-erbB-2/HER2	AVA342G	FDA UDI	Class I	Active
Melanoma Cocktail	CM078B	FDA UDI	Class I	Active
Breast Cocktail (CK HMW/p63 + CK7/8/18)	AVI3203DSKG25	FDA UDI	Class I	Active
Arginase-1	NPAI3058T40	FDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	ALI3279G7	FDA UDI	Class I	Active
Imp3 (rm)	API3180AA	FDA UDI	Class I	Active
Prame [epr20330]	API3252H	EUDAMEDFDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	ALI165G7	FDA UDI	Class I	Active
intelliPATH Plus	IPPLS0001US	FDA UDI	Class I	Active
ONCORE Pro ISHzyme Kit	OPRI6039KT120	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	AVA3291G	FDA UDI	Class I	Active
Amyloid A	CM125A	FDA UDI	Class I	Active
Cd39 [epr20627]	AVI3283G	FDA UDI	Class I	Active
Dog1	CM385C	FDA UDI	Class I	Active
Cd103 (rm)	ACI3117B	FDA UDI	Class I	Active
HPV Type 51 Probe (Digoxigenin)	BPA4052T60	FDA UDI	Class I	Active
20q13.2 Aqua	PFA7325V	FDA UDI	Class I	Active
Warp Red Chromogen Kit	WR806MCK	FDA UDI	Class I	Active
Satb2 [cl0323]	ACI3259B	FDA UDI	Class I	Active
Plap	CRM350A	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	VP011G25	FDA UDI	Class I	Active
URO-3 Triple Stain (CD44+p53) with CK20	PM370TSAA	FDA UDI	Class I	Active
RISH™ Epstein-Barr Encoded RNA (EBER) Probe	OPPA0001T60	FDA UDI	Class I	Active
Pms2	PM344H	FDA UDI	Class I	Active
Stag1	AVI3250G	FDA UDI	Class I	Active
Cd34	CM084C	FDA UDI	Class I	Active
Mum-1	PRM352AA	FDA UDI	Class I	Active
Cd4 [4b12]	API3148AA	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.