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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 26 of 36

Device	Model / Reference	Registries	Class	Status
p53	OPAI298T60	FDA UDI	Class I	Active
Epidermal Growth Factor Receptor (EGFR)	ACI063AK	FDA UDI	Class I	Active
Cd3 [bc33]	ACI3170A	FDA UDI	Class I	Active
Nkx3.1	OPAI422T60	FDA UDI	Class I	Active
Vulcan Fast Red Chromogen Kit 2	FR805-5L	FDA UDI	Class I	Active
Dewax Solution Kit	OPRI6004KT60	EUDAMEDFDA UDI	Class I	Active
Gross Cystic Disease Fluid Protein-15 (GCDFP-15) (Brst-2)	IP113G10	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	API3277AA	FDA UDI	Class I	Active
H3K27me3 [C36B11]	ACI3249C	FDA UDI	Class I	Active
Desmin	IP036G10	FDA UDI	Class I	Active
Aqua DePar 10X	ADP1002M	FDA UDI	Class I	Active
Background Sniper	BS966JJ	FDA UDI	Class I	Active
Ttf-1	CM087B	FDA UDI	Class I	Active
Cdx2	CM226C	FDA UDI	Class I	Active
Folate Receptor alpha IHC Assay Kit	BRI4006KAA	FDA UDI	Class I	Active
Cd34	CM084B	FDA UDI	Class I	Active
p27 KIP1 [Y236]	OPAI3282T60	FDA UDI	Class I	Active
Chromogranin A	CM010B	FDA UDI	Class I	Active
Hla-B [bc43]	ALI3289G7	FDA UDI	Class I	Active
Cd22 [blcam/1796]	ACI3229B	FDA UDI	Class I	Active
WT1 [rWT1/857]	ACI3238A	FDA UDI	Class I	Active
Cd21	NPAI142T40	FDA UDI	Class I	Active
Cd20 [l26]	CM004B	FDA UDI	Class I	Active
Pms2	NPAI344T80	FDA UDI	Class I	Active
Pax5	NPAI207T40	FDA UDI	Class I	Active
Ber-EP4	AVI107G	FDA UDI	Class I	Active
E-cadherin	NPAI170T40	FDA UDI	Class I	Active
ONCORE Pro-Tect Detection Kit	OPRI8005K	FDA UDI	Class I	Active
Ros1 [epmghr2]	ACI3240A	FDA UDI	Class I	Active
CK HMW [34BetaE12]	PM127H	FDA UDI	Class I	Active
Desmin	CM036A	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3+8/18]	IP162G10	FDA UDI	Class I	Active
MART-1 Cocktail	NPAI077T80	FDA UDI	Class I	Active
MACH 2 Double Stain 2	MRCT525L	EUDAMEDFDA UDI	Class I	Active
Msa	PM079AA	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	ACA054A	FDA UDI	Class II	Active
Uroplakin II	AVI3051KG	FDA UDI	Class I	Active
Tim3 [blr033f]	ACI3258A	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	AVI3237G	FDA UDI	Class I	Active
Ck5	CM234A	FDA UDI	Class I	Active
ZipFISH™ Hybridization Buffer	FRI7323C	FDA UDI	Class I	Active
D13S25 (13q14.3) Orange	HFA7266A	FDA UDI	Class I	Active
RISH™ Retrieval 10x	RI0209M	FDA UDI	Class I	Active
Msh6	NPAI265T80	FDA UDI	Class I	Active
Desmoglein 3 + Napsin A	PPM428DSAA	FDA UDI	Class I	Active
Claudin-4	API3121AA	FDA UDI	Class I	Active
Fluoro Care Anti-Fade Mountant	FP001G10	FDA UDI	Class I	Active
Glycophorin A [JC159]	API3272AA	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	NPAA301T40	FDA UDI	Class I	Active
Cd56	CM164B	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.