MAS CardioImmune XL Cardiac Marker Control — Class II medical device recall Z-0501-2015
Terminated recall by Microgenics Corporation, reported 2014-12-10, distributed nationwide. MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinas
| Recall number | Z-0501-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-12-03 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, HK, TW |
| Quantity | 2,135 vials |
| Lot numbers | CXL16011 |
| Model numbers | CAI-XL1 |
| Expiration dates | 2016-01-31 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0501-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.