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U.S. Department of Health and Human Services

Class 2 Device Recall ThermoFisher/Microgenics

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 Class 2 Device Recall ThermoFisher/Microgenicssee related information
Date Initiated by FirmDecember 14, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on October 26, 2012
Recall NumberZ-0637-2012
Recall Event ID 60756
510(K)NumberK061196 
Product Classification Cardiac marker In Vitro Diagnostic - Product Code JJY
ProductThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
Code Information Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013;  CAI-XL1, CXL13011, 31 JAN 2013;  CAI-XL2, CXL13012, 31 JAN 2013;  CAI-XL3, CXL13013, 31 JAN 2013;  CAI-XL4, CXL13014, 31 JAN 2013;  CAI-XLS, CXL1301S, 31 JAN 2013  
FEI Number 3010939897
Recalling Firm/
Manufacturer		 Microgenics Corporation
44660 Osgood Rd
Fremont CA 94539-6410
For Additional Information ContactLisa Charter
412-490-8425
Manufacturer Reason
for Recall		Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 12/14/2011, ThermoFisher Scientific issued letters via express mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
Quantity in Commerce25,113 Kits
DistributionNationwide and Worldwide, including Germany, France, Italy and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJY
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