• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay Systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 3 Recall
Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay Systems
see related information
Date Posted June 26, 2014
Recall Status1 Open
Recall Number Z-1928-2014
Recall Event ID 68469
Premarket Notification
510(K) Number
K052789 
Product Classification Test,Natriuretic Peptide - Product Code NBC
Product Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ® as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ® as an aid in the assessment of severity of congestive heart failure ® for the risk stratification of patients with acute coronary syndromes ® for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
Code Information Lot #328163
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Manufacturer Reason
for Recall
Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Alere sent an Urgent Medical Device Recall letter dated May 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The primary consignees were instructed to block all stock of the affected lot in their warehouses; discontinue use and return all stock on hand, complete the provided verification form to document receipt of the notice and quantity to be returned, contact their primary consignees and advise them of the required discontinuation and return of the affected lot. For customers (or their sub-distributors) who have inventory on hand, Alere San Diego, Inc. will provide replacement product to the customer for the quantity of units that they must return. Customers are instructed to complete the attached reply form with the amount of unused product that will be returned for replacement. Customers with questions are instructed to contact Alere San Diego at 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8287, triage.support@alere.com.
Quantity in Commerce 3,121 kits
Distribution Worldwide Distribution - Nationwide and the countries of 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
-
-