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U.S. Department of Health and Human Services

Class 2 Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KIT

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 Class 2 Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KITsee related information
Date Initiated by FirmJuly 15, 2010
Date PostedAugust 20, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall NumberZ-2243-2010
Recall Event ID 56291
Product Classification ELISA TEST KIT - Product Code NUK
ProductHuman 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.
Code Information Catalog #/Product # BC-1123 Kit lot numbers: RN-27940, 33689, and 37260
Recalling Firm/
Manufacturer		 BioCheck Inc
323 Vintage Park Dr
Foster City CA 94404-1186
For Additional Information Contact
650-573-1968
Manufacturer Reason
for Recall		Products were marketed without 510(k) for diagnostic use. Unapproved device.
FDA Determined
Cause 2		PMA
ActionBioCheck 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 Commerce187 kits
DistributionWorldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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