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Recall Observatory FDA recall evidence

Device product

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Z-1655-2016

March 17, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 73667
Status
Terminated
Classification
Class II
Quantity
137422 units total
Official record key
device-enforcement:Z-1655-2016

Official wording

Reason: 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

Code information: Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721

Distribution pattern: Nationwide: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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

Field note

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