Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a ra
FDA device recall Z-1677-2015 · posted 2015-05-26 · Terminated
Recall details
- Recalling firm
- Alere Scarborough, Inc. dba Binax, Inc.
- Reason for recall
- High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
- Action taken
- Alere sent an Urgent Medical Device Recall letter dated April 23, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop using the product and discard any unused product. Customers asked to complete and return the Verification form within 10 days to confirm receipt of the recall notification and to request credit. For questions about the information contained in the notification, contact Alere Technical Services, Monday through Friday, 8am to 8pm EST. Telephone: (855) 731-2288 or E-mail: t s.scr@alere.com. For questions regarding the status of your credit, please contact your AI ere i distributor or E-mail: ssc.alerefieldactions@alere.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OCC
- Quantity affected
- 213 kits plus 3 - evaluation use only kits
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.
- Date initiated
- 2015-04-22
- Date posted
- 2015-05-26
- Date terminated
- 2016-01-14
- Location
- Scarborough, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALERE I INFLUENZA A & B (K141520) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014-06-13 |