Recall Z-2243-2010 ยท NUK For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
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.
| Date | Aug 20, 2010 (initiated Jul 15, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.