Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Reported: May 18, 2016 Initiated: March 17, 2016 #Z-1663-2016
Product Description
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
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
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 137422 units total
- Distribution
- 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
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista Assays: Direct HDL Cholesterol (AHDL). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 137422 units total.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1663-2016.
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