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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Marker Test

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 Class 2 Recall
Cardiac Marker Test
see related information
Date Posted May 02, 2014
Recall Status1 Open
Recall Number Z-1540-2014
Recall Event ID 67910
Premarket Notification
510(K) Number
K052789 
Product Classification Test,Natriuretic Peptide - Product Code NBC
Product Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
Code Information Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Manufacturer Reason
for Recall
These lots may not recover within range when tested using certain commercially available controls.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Reagent Pack Lots 329599 or 331265, they can receive the Alere Triage® BNP QC Controls PN 98201 by requesting them on the Verification Form. "Customers were instructed to share this information with their laboratory staff, including their laboratorys medical director and retain this notification as part of their laboratory Quality System documentation. For questions regarding this recall call 858-805-2000, ext 3015. " If they have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. " Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice. Only one Verification Form is required per facility. Customers with questions were instructed to call 877-308-8287 or email Triage.Support@alere.com.
Quantity in Commerce 12,592 kits
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBC and Original Applicant = BIOSITE INCORPORATED
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