Z-2243-2010

Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD)...

Name: Z-2243-2010 Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD)...
Creator: BioCheck Inc
Published: 2010-07-15
License: https://open.fda.gov/license/

BioCheck Inc / initiated 2010-07-15 / Terminated

FDA source

BioCheck Inc began a recall of 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... on 2010-07-15. The reason FDA records is "Products were marketed without 510(k) for diagnostic use. Unapproved device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2243-2010
Status: Terminated
Initiated: 2010-07-15
Posted: 2010-08-20
Terminated: 2010-12-13
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.
Product code: NUK For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
Reason for recall: Products were marketed without 510(k) for diagnostic use. Unapproved device.
FDA 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 in commerce: 187 kits
Distribution: Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
Product codes and lots: Catalog #/Product # BC-1123 Kit lot numbers: RN-27940, 33689, and 37260

Product code NUK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)