Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Recall date

March 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1653-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)