Microgenics Corporation: 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.

Recall number

Z-0501-2015

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.

Status

Terminated

Initiated

2014-10-20

Posted

2014-12-04

Terminated

2015-03-30

Reason

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

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 mas.controls@thermofisher.com 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

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.

Lot, serial or model codes

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

510(k) numbers

["K061196"]

PMA numbers

not on file

Product code

JJY

Firm FEI

3010939897

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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