Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorize
FDA device recall Z-2243-2010 · posted 2010-08-20 · Terminated
Recall details
- Recalling firm
- BioCheck Inc
- Reason for recall
- Products were marketed without 510(k) for diagnostic use. Unapproved device.
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- NUK
- Quantity affected
- 187 kits
- Distribution
- Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
- Date initiated
- 2010-07-15
- Date posted
- 2010-08-20
- Date terminated
- 2010-12-13
- Location
- Foster City, CA
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