Recall Z-1651-2016 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
| Date | Mar 17, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | Siemens 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 i |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023504 | MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc., Nov 13, 2002 |