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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA 2400 Chemistry System

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  Class 2 Device Recall ADVIA 2400 Chemistry System see related information
Date Initiated by Firm February 17, 2006
Date Posted August 29, 2006
Recall Status1 Terminated 3 on May 24, 2012
Recall Number Z-1450-06
Recall Event ID 35880
510(K)Number K990346  
Product Classification Automated Clinical Chemistry Analyzer - Product Code JGS
Product Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Code Information Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
Recalling Firm/
Manufacturer		 Bayer Healthcare, LLC (Diagnostics Division)
511 Benedict Avenue
Tarrytown NY 10591-5097
For Additional Information Contact Mr. Steven Andberg
508-660-8540
Manufacturer Reason
for Recall		 Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.
FDA Determined
Cause 2		 Other
Action Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected customers.
Quantity in Commerce 1138 for all products
Distribution Worldwide including USA and Puerto Rico.
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.
510(K) Database 510(K)s with Product Code = JGS and Original Applicant = BAYER CORP.
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