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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 21 of 36

Device	Model / Reference	Registries	Class	Status
Pan Cytokeratin [AE1/AE3]	CM011B	FDA UDI	Class I	Active
Cd137 [blr051f]	ACI3264A	FDA UDI	Class I	Active
p16 INK4a [BC42]	API3231H	FDA UDI	Class I	Active
Pd-L1	ACI3171A	FDA UDI	Class I	Active
Progesterone Receptor (PR) [SP2]	ACI302A	FDA UDI	Class I	Active
Cd4 [4b12]	ACI3148A	FDA UDI	Class I	Active
Claudin-4	ACI3121B	FDA UDI	Class I	Active
Cd99	PME392AA	FDA UDI	Class I	Active
Synaptophysin	AVI371G	FDA UDI	Class I	Active
Monet Blue Diluent	PD901L	EUDAMEDFDA UDI	Class I	Active
Ber-EP4	NPAI107T80	FDA UDI	Class I	Active
Prame [epr20330]	API3252AA	EUDAMEDFDA UDI	Class I	Active
E-Cadherin (RM)	ACI3012A	FDA UDI	Class I	Active
Cd68 [kp1]	NPAI033T40	FDA UDI	Class I	Active
Mum-1	CRM352B	FDA UDI	Class I	Active
Nkx3.1	CP422B	FDA UDI	Class I	Active
Ca 19-9	CM123A	FDA UDI	Class I	Active
Ck8/18 (rm)	API3161AA	FDA UDI	Class I	Active
Cd71	ACI3110B	FDA UDI	Class I	Active
MACH 4 Universal AP-Polymer Kit	M4U536L	EUDAMEDFDA UDI	Class I	Active
Glucagon	ACI3276C	FDA UDI	Class I	Active
c-Myc	CME415CK	FDA UDI	Class I	Active
6q21 Green	HFA7309A	FDA UDI	Class I	Active
GCDFP-15 + Mammaglobin	PM317DSAA	FDA UDI	Class I	Active
Tle 1 [epr9386(2)]	ALI3301G7	FDA UDI	Class I	Active
p63	PM163AA	FDA UDI	Class I	Active
Pcna [pc10]	API3255AA	FDA UDI	Class I	Active
Background Eraser	BE965H	FDA UDI	Class I	Active
Cd3 [ln10]	ACI3152A	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	IPI165G10	FDA UDI	Class I	Active
Gcdfp-15	PM113AA	FDA UDI	Class I	Active
FGFR3 (4p16.3) Orange	HFA7277A	FDA UDI	Class I	Active
Calcitonin	PP072AA	FDA UDI	Class I	Active
Tdt (P)	CP134AK	FDA UDI	Class I	Active
Trbc1	ALI3280G7	FDA UDI	Class I	Active
Prostate Specific Antigen (PSA)	NPAI390T40	FDA UDI	Class I	Active
Prostate Specific Antigen (PSA)	PME390AA	FDA UDI	Class I	Active
CK5/14 + p63 + P504S	NPAI225DST40	FDA UDI	Class I	Active
Mlh-1	CM220CK	FDA UDI	Class I	Active
Tle 1 [epr9386(2)]	ACI3301A	FDA UDI	Class I	Active
Phospho-Histone H3	CP404C	FDA UDI	Class I	Active
Brca-1	CM345A	FDA UDI	Class I	Active
Sma	CM001B	FDA UDI	Class I	Active
Gata-3	CM405A	FDA UDI	Class I	Active
Automation Tween 20, 20X	TWA20M	FDA UDI	Class I	Active
Diva Decloaker 10X	DV2004LX	FDA UDI	Class I	Active
Cd138	CM167CK	FDA UDI	Class I	Active
Chromogranin A	AVI010G	FDA UDI	Class I	Active
Amacr (rm), 2x	APA3016AA	FDA UDI	Class I	Active
c-erbB-2/HER2	APA342H	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.