| Class 2 Device Recall Alere Triage Profiler SOB Panel | |
Date Initiated by Firm | March 05, 2012 |
Date Posted | April 26, 2012 |
Recall Status1 |
Terminated 3 on December 04, 2012 |
Recall Number | Z-1467-2012 |
Recall Event ID |
61516 |
510(K)Number | K080269 |
Product Classification |
Immunoassay method, troponin subunit - Product Code MMI
|
Product | Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes. |
Code Information |
Lot Code: W48990 Phase 2 (June 12, 2012): Lot#W50019, W50027 |
Recalling Firm/ Manufacturer |
Alere San Diego 9975 Summers Ridge Rd San Diego CA 92121-2997
|
For Additional Information Contact | 858-455-4808 Ext. 3015 |
Manufacturer Reason for Recall | Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing. |
FDA Determined Cause 2 | Process control |
Action | A recall communication was initiated on 3/15/12 with Alere San Diego, Inc. forwarding a "Urgent Medical Device Recall" letter to all their customers who purchased the Alere Triage CardioProfiler Panel PN 97100CP, Lot W49569 and Alere Triage Profiler SOB Panel PN 97300, Lot W48990. The letter informed the customers about the problems identified and the actions to be taken. Customers with any questions about the information contained in this notification should contact Alere San Diego, Inc. at (877) 308-8287. |
Quantity in Commerce | 1,316 kits |
Distribution | Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait. |
Total Product Life Cycle | TPLC 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.
|
510(K) Database | 510(K)s with Product Code = MMI
|
|
|
|