FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Recall number
- Z-1231-2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Status
- Terminated
- Initiated
- 2019-12-18
- Posted
- 2020-01-24
- Terminated
- 2020-06-25
- Reason
- There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- Root cause
- Under Investigation by firm
- Action
- Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
- Quantity
- 824 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- UDI Number: 00630414595795 Lots: All lots
- 510(k) numbers
- ["K070727"]
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- 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