Recall Z-2280-2020 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.
| 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 | 5 |
| 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
| K131307 | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR Siemens Healthcare Diagnostics, Inc., Jan 24, 2014 |