Z-0501-2015Class II

MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an...

Name: Z-0501-2015 MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an...
Creator: Microgenics Corporation
Published: 2014-10-20
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2014-10-20 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corporation began a recall of MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay... on 2014-10-20. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0501-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-20
Posted: 2014-12-04
Terminated: 2015-03-30
Recalling firm: Microgenics Corporation
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.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ThermoFisher sent an Urgent Medical Device Field Corrections dated October 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Foreign customers were sent letters via overnight mail and e-mail. ACTIONS TO BE TAKEN BY THE CUSTOMER: 1. Determine if you are using or have inventory of MAS Cardiolmmune XL, lot CXL16011. 2. Discontinue use and destroy any remaining inventory of MAS Cardiolmmune XL, lot CXL16011 per your local waste ordinances. 3. Retain a copy of this letter for your laboratory records. 4. If you have forwarded kits of MAS Cardiolmmune XL (lot CXL16011) to another laboratory, please provide a copy of this letter to them. 5. Complete the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form below. 6. Please call technical service at 1-800-232-3342, then press option 2, then option 2 or e-mail [email protected] to arrange immediate product replacement. If you are a distributor of the product, please contact your affected customer base, advise them of the situation, and provide them with a copy of this letter. You should insert your contact information, e-mail and fax numbers in the Medical Device Field Correction Response Form and request that they return the form to you. You should fill out the distributor section of the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form. Firm intends to try to get a response twice more by mail or telephone to insure we reach all customers. Affected product remaining at firm is quarantined and will be destroyed.
Quantity in commerce: 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 and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
Product codes and lots: Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0501-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03

Product code JJY

K061196Class ICardioimmune Xl Cardiac Marker ControlMicrogenics Corp. / cleared 2006-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)