FDA Medical Device Recalls (openFDA)
BioCheck Inc: Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
- Recall number
- Z-2243-2010
- Recalling firm
- BioCheck Inc
- Product
- Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
- Status
- Terminated
- Initiated
- 2010-07-15
- Posted
- 2010-08-20
- Terminated
- 2010-12-13
- Reason
- Products were marketed without 510(k) for diagnostic use. Unapproved device.
- Root cause
- PMA
- Action
- BioCheck sent an "Urgent Device Recall" letter dated July 15, 2010 to consignees identifying the products as unapproved and requesting prompt return to the firm. Consignees are asked to sub-recall. The letter requested a reponse form be completed and returned to the firm. Diagnostic claims have been removed from the website. Returned product will be quarantined by the firm pending determination of marketing status and labeling revision.
- Quantity
- 187 kits
- Distribution
- Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
- Lot, serial or model codes
- Catalog #/Product # BC-1123 Kit lot numbers: RN-27940, 33689, and 37260
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NUK
- Firm FEI
- 3002564473
- Firm city
- Foster City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28