FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2282-2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-05-04
- Posted
- 2020-06-05
- Terminated
- 2021-09-20
- 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 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.
- 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, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.
- Lot, serial or model codes
- Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374
- 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