Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on t
FDA device recall Z-2095-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Alere Scarborough, Inc. dba Binax, Inc.
- Reason for recall
- Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
- Action taken
- Alere sent a Urgent Medical Device Recall letter dated June 26, 2015, to all affected consignees. Customers were instructed to cease use and discard any unused pouched Sample Receivers and Transfer Cartridges contained in Alere" i Influenza A & B PN 425-024, Lot 0073853. Pouched Sample Receivers and Transfer Cartridges are identified in the kit as part number 425-431 lot number 074005 or 074108. Replacement Sample Receivers and Transfer Cartridges will be provided to the customer. Customers with questions were instructed to call Alere Technical Services at 855-731-2288 or email ts.scr@alere.com.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- OCC
- Quantity affected
- 257 Kits
- Distribution
- Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
- Date initiated
- 2015-06-26
- Date posted
- 2015-07-16
- Date terminated
- 2015-09-15
- 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 |