MAS CardioImmune XL Cardiac Marker Control; 의 리콜

Recall

69670

Class 2

Z-0501-2015

2014-10-20

2014-12-04

Terminated

United States

2015-03-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131305

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).

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.