Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Reported: February 26, 2020 Initiated: December 18, 2019 #Z-1231-2020
Product Description
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 824 units
- Distribution
- US Nationwide
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 824 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1231-2020.
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