CLASS II Device recall · Reported 10 Dec 2014 · FDA Enforcement Report
MAS CardioImmune XL Cardiac Marker Control recalled by Microgenics
Microgenics is recalling MAS CardioImmune XL Cardiac Marker Control, distributed nationwide in the US. The recall was initiated on 20 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0501-2015
- FDA event ID
- 69670
- Recalling firm
- Microgenics, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2014
- FDA classified
- 3 Dec 2014
- Reported
- 10 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 20 Oct 2014 | Recall initiated by company | |
| 3 Dec 2014 | Classified by FDA | +44 days |
| 10 Dec 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
Where was it sold?
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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