Recall Z-2282-2020 ยท JFY Enzymatic Method, Creatinine
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
| Date | Jun 5, 2020 (initiated May 4, 2020) |
| Status | Terminated |
| Reason | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| Root cause | Device Design |
| Action | On May 4, 2020, Siemens notified their customers that use the Fructosamine and Enzymatic Creatinine assays on the Atellica, ADVIA, and Dimension platforms of the potential for falsely depressed results in the presence of NAPQI. An Urgent Medical Device Correction Notice was sent to consignees in the US and an Urgent Field Safety Notice was sent to customers outside the US. The letter stated that the Limitations of the Procedure section of the Instructions for Use (IFU) will be updated with specific information related to the assay/platform. Customers were asked to complete and return the Effec |
| Quantity | 1006 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Medical Solutions Diagnostics, Aug 3, 2007 |