Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
Recall
- Recall Number
- Z-1651-2016
- Event Number
- 73667
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- CHH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 17, 2016
- Terminated
- September 25, 2017
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466
Description
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
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
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 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.
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
137422 units total