Recall Z-1662-2016— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1662-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-03-17, terminated 2017-09-25. It names one FDA 510(k) clearance: K862359. Product: Dimension Assays: Uric Acid (URCA). 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.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Terminated: 2017-09-25
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K862359 — METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEME.I. Dupont DE Nemours & Co., Inc.·cleared 1986-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dimension Assays: Uric Acid (URCA)

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

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