Alere Scarborough, Inc. dba Binax, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2095-2015Class IIAlere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B June 26, 2015
Z-1677-2015Class IIAlere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the AleApril 22, 2015