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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & Concentrated

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 Class 2 Device Recall ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & Concentratedsee related information
Date Initiated by FirmMarch 17, 2016
Create DateMay 11, 2016
Recall Status1 Terminated 3 on September 25, 2017
Recall NumberZ-1657-2016
Recall Event ID 73667
510(K)NumberK133067 
Product Classification Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
ProductADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Code Information Device Listing: D126071, Triglyceride_2, Catalog # 74082 Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information ContactMindy Losapio
914-524-2312
Manufacturer Reason
for Recall		Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
FDA Determined
Cause 2		Device Design
ActionSiemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.
Quantity in Commerce137422 units total
DistributionNationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
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 = CDT
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