Alere San Diego Inc. DBA Immunalysis Corporation

FDA Regulatory Profile

Alere San Diego Inc. DBA Immunalysis Corporation appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2140-2018, Class III) was initiated on November 28, 2017.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2140-2018Class IIIlmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) arNovember 28, 2017