Recall Z-0501-2015— Microgenics Corporation
Class II · Terminated
Class II FDA medical device recall by Microgenics Corporation, initiated 2014-10-20, terminated 2015-03-30. It names one FDA 510(k) clearance: K061196. Product: MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.. Reason: MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32)..
- Recalling firm
- Microgenics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-20
- Terminated
- 2015-03-30
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Reason for recall
MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
Data sourced from openFDA. This site is unofficial and independent of the FDA.