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U.S. Department of Health and Human Services

Class 3 Device Recall STAT High Sensitive TroponinI Calibrators

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  Class 3 Device Recall STAT High Sensitive TroponinI Calibrators see related information
Date Initiated by Firm April 09, 2019
Create Date May 16, 2019
Recall Status1 Terminated 3 on December 20, 2019
Recall Number Z-1360-2019
Recall Event ID 82590
Product Classification Calibrator, secondary - Product Code JIT
Product ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Code Information LN 3P25-02; Lot 93284UIOO
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd Bldg Ap8b
Abbott Park IL 60064-3502
For Additional Information Contact Albert Chianello
224-668-1923
Manufacturer Reason
for Recall		 Devices were delivered without the required dry ice.
FDA Determined
Cause 2		 Under Investigation by firm
Action On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.
Quantity in Commerce 3 units
Distribution Distribution to Latvia.
Total Product Life Cycle TPLC 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.
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