Recalls / —
—#179252
Product
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- FDA product code
- JFY — Enzymatic Method, Creatinine
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K070727
- Affected lot / code info
- UDI Number: 00630414595795 Lots: All lots
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 511 Benedict Ave, Tarrytown, New York 10591-5005
Distribution
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2019-12-18
- Posted by FDA
- 2020-01-24
- Terminated
- 2020-06-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.