Biocheck, Inc.
United StatesFDA applicant, unverified FDA FEI 3002564473
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 19
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 14 devicesCompany details
- FDA FEI number
- 3002564473
- Address
- 3451 Vincent Rd, Pleasant Hill, CA, 94523
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 14 Oct 2021 Z-0214-2022 Class II Terminated Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Full distribution text
- 14 Oct 2021 Z-0214-2022 Class II Terminated Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
2010
- 22 Dec 2010 Z-1626-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1627-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1628-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1629-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1630-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1631-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1632-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1633-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1634-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Show all 19 recalls
2010
- 22 Dec 2010 Z-1635-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1636-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1637-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1638-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1639-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1640-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1641-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 22 Dec 2010 Z-1642-2011 Unclassified (pre-2012) Terminated Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 15 Jul 2010 Z-2243-2010 Unclassified (pre-2012) Terminated Products were marketed without 510(k) for diagnostic use. Unapproved device.
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Frequently asked questions
How many devices does Biocheck, Inc. have in the registry?
The registry currently lists 14 devices for Biocheck, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocheck, Inc.'s devices?
Among its 14 most recently registered devices, Biocheck, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Biocheck, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Biocheck, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Biocheck, Inc.?
FDA recall records list 19 recalls initiated by Biocheck, Inc., the most recent initiated on 14 Oct 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Biocheck, Inc. in the registry?
The most recently registered devices listed for Biocheck, Inc. include BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027, BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119, BIOCHECK IGE ELISA, MODEL BC-1035 and BIOCHECK FERRITIN ELISA MODEL BC-1025.