—#144704

Product

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

FDA product code: KNK — Acid, Uric, Uricase (Colorimetric)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K991576
Affected lot / code info: Device Listing: Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated (UA_c) - D033081, Catalog # 74715

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2016-03-17
Terminated: 2017-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144704. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.