Recall Z-1666-2016
Siemens Healthcare Diagnostics, Inc. · initiated March 17, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista Assays: Uric Acid (URCA)
Codes / lots: Device Listing: D011436 - Uric Acid (URCA), Catalog # K1077
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1666-2016
- Initiated
- March 17, 2016
- Terminated
- September 25, 2017
- Product code
- KNK – Acid, Uric, Uricase (Colorimetric)
- 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
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1651-2016 Class II | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL CholesterolSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1652-2016 Class II | Advia Chemistry Assay: LDL Cholesterol, DirectSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1653-2016 Class II | Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1654-2016 Class II | ADVIA CHEMISTRY ENZYMATIC CREATININE_2Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1655-2016 Class II | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose…Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1656-2016 Class II | Advia Chemistry Assay: LactateSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1657-2016 Class II | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2…Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1658-2016 Class II | Advia Chemistry Assay: Uric Acid and Uric Acid, concentratedSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1659-2016 Class II | Dimension Assays: Direct HDL Cholesterol (AHDL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1660-2016 Class II | Dimension Assays: ENZYMATIC CREATININESiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1661-2016 Class II | Dimension Assays: Triglycerides (TGL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1662-2016 Class II | Dimension Assays: Uric Acid (URCA)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1663-2016 Class II | Dimension Vista Assays: Direct HDL Cholesterol (AHDL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1664-2016 Class II | Dimension Vista Assays: Enzymatic Creatine (ECRE)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |
| Z-1665-2016 Class II | Dimension Vista Assays: Triglycerides (TRIG)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | 03/17/2016Terminated |