ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
FDA device recall Z-1230-2020 · posted 2020-01-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1,015 units
- Distribution
- US Nationwide
- Date initiated
- 2019-12-18
- Date posted
- 2020-01-24
- Date terminated
- 2020-06-25
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (K070727) | Siemens Medical Solutions Diagnostics | 2007-08-03 |