FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- Recall number
- Z-1654-2016
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- Status
- Terminated
- Initiated
- 2016-03-17
- Posted
- not on file
- Terminated
- 2017-09-25
- 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 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.
- 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
- Lot, serial or model codes
- Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330
- 510(k) numbers
- ["K070727"]
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28