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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Systems Acetaminophen Nacetylcysteine (NAC)

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 Class 2 Device Recall ADVIA Chemistry Systems Acetaminophen Nacetylcysteine (NAC)see related information
Date Initiated by FirmJune 30, 2015
Date PostedAugust 19, 2015
Recall Status1 Terminated 3 on September 01, 2016
Recall NumberZ-2416-2015
Recall Event ID 71710
510(K)NumberK100200 
Product Classification Colorimetry, acetaminophen - Product Code LDP
ProductADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
Code Information Catalog Number 07989138, Siemens Material Number (SMN) 10327381, Lot Numbers: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558; with expiration dates June 30, 2015 through April 30, 2016.   
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information ContactCustomer Support
800-441-9250
Manufacturer Reason
for Recall		A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionSiemens sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. Siemens Healthcare Diagnostics is conducting a voluntary recall for the ADVIA Chemistry Acetaminophen reagent, for all in date and future kit lots. Customers were informed of the revised interference levels of N-acetyl cysteine (NAC) of 200 mg/dL, for the ADVIA Chemistry Acetaminophen assay. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions call 1 (800) 441-9250.
Quantity in Commerce1032
DistributionWorldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
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 = LDP
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