Recall Z-2281-2020
Siemens Healthcare Diagnostics, Inc. · initiated May 4, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 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.
Codes / lots: Lot # 291011 ***Added 9/9/20*** 201115
Reason for recall
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
FDA-determined cause: Device Design
Action taken
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 Effectiveness Check questionnaire attached to the letter within 30 days. In addition, customers were informed that field service personnel will be sent an Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions.
Details
- Recall number
- Z-2281-2020
- Initiated
- May 4, 2020
- Posted by FDA
- June 5, 2020
- Terminated
- September 20, 2021
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 26
- 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, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2280-2020 Class II | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | 05/04/2020Terminated |
| Z-2282-2020 Class II | ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | 05/04/2020Terminated |
| Z-2283-2020 Class II | Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | 05/04/2020Terminated |
| Z-2284-2020 Class II | Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | 05/04/2020Terminated |
| Z-2285-2020 Class II | Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number…The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference… | 05/04/2020Terminated |