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Terminated

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

FDA Recall Z-1655-2016 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2016-03-17
Date Terminated2017-09-25
Product Quantity137422 units total

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

Firm 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 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.

Root Cause

Device Design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042015ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASEBayer Healthcare, Diagnostics Division · 2004-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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