Abbott Point of Care Canada Limited

FDA Regulatory Profile

Abbott Point of Care Canada Limited appears in FDA public data with 1 recall, 0 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0716-2013, Class II) was initiated on November 1, 2012.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0716-2013Class IIAbbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in viNovember 1, 2012