The Recall Desk
ModerateFDA (Devices)·Z-0501-2015·Announced 2014-12-10

Microgenics Recalls MAS CardioImmune XL Cardiac Marker Control Due to Variation

Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control (Lot CXL16011) because the product shows vial-to-vial variation for specific analytes.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a quality control issue (vial-to-vial variation) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall.

Plain-English summary

Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control, Model CAI-XL1, Lot CXL16011. The product is intended for use in clinical laboratories as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

The recall was initiated because the product is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32). This variation may affect the reliability of the control serum in monitoring assay conditions.

The affected product was distributed nationwide in the United States, including Puerto Rico, and internationally to Australia, Canada, China, Germany, Guam, Hong Kong, and Taiwan. Clinical laboratories should stop using the affected lot and contact Microgenics Corporation for instructions on return or replacement.

The recalled product

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.
Manufacturer
Microgenics Corporation
Category
Medical Device — Laboratory Control
Hazard
Affected units
2,135

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No.: CAI-XL1
  • Lot Number: CXL16011
  • Exp. Date: 2016-01-31.

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Related recalls

Same manufacturer · Microgenics Corporation

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