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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 29 of 36

Device	Model / Reference	Registries	Class	Status
Estrogen Receptor (ER) [6F11 + SP1]	APA308AA	FDA UDI	Class II	Active
Msh2	CM219CK	FDA UDI	Class I	Active
Lag3 [cal26]	API3213AA	FDA UDI	Class I	Active
Glypican-3	PM396AA	FDA UDI	Class I	Active
Prame [epr20330]	NPAI3252T80	FDA UDI	Class I	Active
Lambda Light Chain [N10/2]	API3063AA	FDA UDI	Class I	Active
intelliPATH FLX™ Multiplex Secondary Reagent 2	IPSC5004G20	EUDAMEDFDA UDI	Class I	Active
Background Terminator	BT967L	FDA UDI	Class I	Active
intelliPATH™ Universal HRP Detection Kit	IPK5011G80	EUDAMEDFDA UDI	Class I	Active
Chromogranin A	PM010AA	FDA UDI	Class I	Active
Mlh-1	NPAI220T80	FDA UDI	Class I	Active
Cd163	PM353AA	FDA UDI	Class I	Active
Uroplakin III	ACI3023C	FDA UDI	Class I	Active
Vimentin	PM048AA	FDA UDI	Class I	Active
Muscle Specific Actin (MSA)	NPAI079T40	FDA UDI	Class I	Active
Erg	OPAI421T60	FDA UDI	Class I	Active
Da Vinci Green Diluent	PD900M	EUDAMEDFDA UDI	Class I	Active
Cd3 [bc33]	OPAI3170T60	FDA UDI	Class I	Active
Uroplakin II	AVI3051KG25	FDA UDI	Class I	Active
Mlh-1 [bc23]	API3214H	FDA UDI	Class I	Active
Ck 5/6	CM105A	FDA UDI	Class I	Active
Beta-Catenin	CM406C	FDA UDI	Class I	Active
E-Cadherin (RM)	API3012AA	FDA UDI	Class I	Active
Cdx2 [bc39]	AVI3184G	FDA UDI	Class I	Active
Cd138	PM167AA	FDA UDI	Class I	Active
Ca-9	AVI3285G	FDA UDI	Class I	Active
Cd19	PM310AA	FDA UDI	Class I	Active
Cdx2	ALI226G7	FDA UDI	Class I	Active
Diva Decloaker RTU	DV2004MM	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	APA301AA	FDA UDI	Class II	Active
Progesterone Receptor (PR) [PgR636]	API343H	FDA UDI	Class I	Active
IGH (14q32) Variable Green	HFA7279A	FDA UDI	Class I	Active
Pd-L1	ACI3171C	FDA UDI	Class I	Active
Copy Control 6q11.1 Aqua	PFA7179V	FDA UDI	Class I	Active
Gitr [cal8]	ACI3221B	FDA UDI	Class I	Active
HIF-1 alpha	CME349B	EUDAMEDFDA UDI	Class I	Active
Mcm2 + Top2a	AVI3181G	FDA UDI	Class I	Active
Thyroglobulin Cocktail	CM022A	FDA UDI	Class I	Active
Gfap (p)	CP040A	FDA UDI	Class I	Active
DAB Sparkle	DS830H	FDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	ACI3279A	FDA UDI	Class I	Active
Cdx2 (rm)	ACI3144B	FDA UDI	Class I	Active
pHH3 (RM)	ACI3130A	FDA UDI	Class I	Active
Prame [epr20330]	ACI3252B	EUDAMEDFDA UDI	Class I	Active
CK HMW [34BetaE12]	ALI127G7	FDA UDI	Class I	Active
Universal Negative Control Serum	NC498AA	EUDAMEDFDA UDI	Class I	Active
Calretinin	ALI092G7	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	APR3278AA	FDA UDI	Class I	Active
p16 + Ki-67	API3246DSAA	FDA UDI	Class I	Active
Pax8	CP379CK	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.