Recall Z-1931-2012
Alere San Diego, Inc. · initiated May 22, 2012
Class I – dangerous or defective products that could cause serious health problems or death
Product
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Codes / lots: Phase 1: K50671B, W49486B, W49487B, W49489B, W49498B, W49500B, W49873B, W49890B, W49895B, W49896B, W49934B, W49947B, W49948B, W49950B, W49962B, W49968B, W50257B, W50278B, W50279B, W50282B, W50287B, W50294B, and W50313B. Phase 2: K50665B, W49855B, W49862B, W49865B, W49887B, W49892B, W49893B, W49894B, W49900B, W49933B, W49939B, W49953B, W49958B, W49960B, W49961B, W50252B, W50268B, W50273B, W50274B, W50290B, W50292B, W50295B, W50297B, W50298B, W50304B, W50355B, W50357B, and W50375B.
Reason for recall
Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
FDA-determined cause: Process design
Action taken
Phase 1 of the recall included a recall communication being initiated on May 22, 2012 with Alere forwarding a recall letter to all their customers who purchased the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use of the affected product, and to complete and fax the enclosed verification form within 10 days. Phase 2 of the recall included a recall communication letter being forwarded to customers on 6/11/12. The second letter included additional lots of Triage products that go beyond the lots included in an earlier recall notification letter. The letter informed the customers that the additional lots have significantly decreased precision relative to the package insert which could result in an increased frequency of false positive or false negative results. A third letter dated June 12, 2012 included 3 more lots for the Triage Cardio Profiler Panel PN 97100CP and Alere Triage Profiler SOB Panel PN 97300. The letter informed the customers that the additional lots have an increased frequency of Troponin I results >0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing. Customers with questions about the information contained in the notifications, were instructed to contact Alere San Diego at (877) 308-8287 or at 9975 Summers Ridge Road, San Diego, CA 92121.
Details
- Recall number
- Z-1931-2012
- Initiated
- May 22, 2012
- Posted by FDA
- July 6, 2012
- Terminated
- October 18, 2013
- Product code
- NBC – Test, Natriuretic Peptide
- Quantity
- 30,083 kits
- Distribution
- Nationwide Distribution
- Recalling firm
- Alere San Diego, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1928-2012 Class I | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of…Certain lots of the affected products may have significantly decreased precision relative to the package… | 05/22/2012Terminated |
| Z-1929-2012 Class I | Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of…Certain lots of the affected products may have significantly decreased precision relative to the package… | 05/22/2012Terminated |
| Z-1930-2012 Class I | Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase…Certain lots of the affected products may have significantly decreased precision relative to the package… | 05/22/2012Terminated |
| Z-1932-2012 Class I | Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients…Certain lots of the affected products may have significantly decreased precision relative to the package… | 05/22/2012Terminated |