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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 8 of 36

Device	Model / Reference	Registries	Class	Status
Cdx2	NPAI226T40	FDA UDI	Class I	Active
Ros1 [epmghr2]	ALI3240G7	FDA UDI	Class I	Active
Cd99	ALI392G7	FDA UDI	Class I	Active
HMW CK + p63 (Basal Cell Cocktail)	ALI210G7	FDA UDI	Class I	Active
Ki-67	AVI325G	FDA UDI	Class I	Active
Starr Trek Universal HRP Detection	STUHRP700L10-KIT	EUDAMEDFDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	AVI3279G	FDA UDI	Class I	Active
Pd-L1	NPAI3171T40	FDA UDI	Class I	Active
Cytokeratin 18 (CK 18)	ACI3061C	FDA UDI	Class I	Active
Cytomegalovirus (CMV)	NPAA118T40	FDA UDI	Class I	Active
Factor VIII	PP039AA	FDA UDI	Class I	Active
Spirochete	API135AA	FDA UDI	N	Active
Melan A (M)	API3114AA	FDA UDI	Class I	Active
CD1a [O10]	ACI3158B	FDA UDI	Class I	Active
Kappa (M) + Lambda (P)	API3159DSAA	FDA UDI	Class I	Active
Foxp3 [86d]	ACI3197A	FDA UDI	Class I	Active
RB1 (13q14.2) Green	HFA7315A	FDA UDI	Class I	Active
Mlh-1 [bc23]	API3214AA	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	ACI301B	FDA UDI	Class II	Active
Satb2 [cl0323]	AVI3259G	FDA UDI	Class I	Active
Pan Lymphoma Cocktail (LCA+CD20+CD3+CD43)	API3035AA	FDA UDI	Class I	Active
Sox10 (m)	API3099AA	FDA UDI	Class I	Active
Cd5 (m)	CM099C	FDA UDI	Class I	Active
Sox10 (m)	IPI3099G10	FDA UDI	Class I	Active
Ber-EP4	ALI107G7	FDA UDI	Class I	Active
Muscle Specific Actin (MSA)	IP079G10	FDA UDI	Class I	Active
p16 INK4a [BC42]	ALI3231G7	FDA UDI	Class I	Active
Ck7	IP339G10	FDA UDI	Class I	Active
Mum-1	OPAI352T60	FDA UDI	Class I	Active
Tia-1	NPAI130T40	FDA UDI	Class I	Active
Cd10 [umab236]	API3212AA	FDA UDI	Class I	Active
Lmo2 [sp51]	ACI3262A	FDA UDI	Class I	Active
Msh6 [bc19]	ACI3215C	FDA UDI	Class I	Active
Diva Decloaker 10X	DV2004MX	FDA UDI	Class I	Active
c-erbB-2/HER2	OPAA342T60	FDA UDI	Class I	Active
Immunocare TBS Wash Buffer 10X	TWB943M	EUDAMEDFDA UDI	Class I	Active
Avidin Biotin Kit	AB972L	EUDAMEDFDA UDI	Class I	Active
Cd3 (m)	CM110AK	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	API3154DSAA	FDA UDI	Class I	Active
Warp Red Chromogen Kit	WR806S	FDA UDI	Class I	Active
Cd45ro [uchl-1]	CM006C	FDA UDI	Class I	Active
4+ Biotinylated Universal Goat Link	GU600H	EUDAMEDFDA UDI	Class I	Active
Treponema pallidum (Spirochete)	APA135AA	FDA UDI	Class I	Active
Vimentin	AVI048G	FDA UDI	Class I	Active
V-Blocker	BRI4001G	FDA UDI	Class I	Active
Pax8	NPAI379T80	FDA UDI	Class I	Active
PSAP [rACPP/1338]	OPAI3263T60	FDA UDI	Class I	Active
Cd54 [e3q9n]	AVI3296G	FDA UDI	Class I	Active
PSAP [rACPP/1338]	ACI3263A	FDA UDI	Class I	Active
Stat6 [ye361]	ACI3244C	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.