FDA Device recall Z-0501-2015
MAS CardioImmune XL Cardiac Marker Control
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of MAS CardioImmune XL Cardiac Marker Control by Microgenics, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-20 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microgenics |
| Distribution | US |
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).
Identifiers
| code_info | Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2015%22
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