Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 10, 2014
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.
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).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microgenics Corporation recalled MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the c… - a moderate-severity action.
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the c… was recalled by Microgenics Corporation in December 10, 2014. Reason: MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kina…. Check the official notice for the remedy. Verify recall #Z-0501-2015 with the FDA Devices before acting.
The recall
Microgenics Corporation issued this moderate-severity FDA Devices recall-MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kina….
- Moderate
- severity level
- Class II
- classification
- December 10, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0501-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0501-2015) was formally reported on December 10, 2014, with the manufacturer initiating the action on October 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Microgenics Corporation is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as 2135 vials..
The documented reason for this recall is: 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). Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2135 vials.
Related Recalls
6
3 from same agency
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0501-2015 |
| Date reported | December 10, 2014 |
| Date initiated | October 20, 2014 |
| Recalling firm | Microgenics Corporation |
| Firm location | Fremont, CA |
| Affected scope | 2135 vials. |
| Distribution | 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0501-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microgenics Corporation. Units affected: 2135 vials..
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0501-2015.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0501-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 10, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.