Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN… recallZ-1231-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 18, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Recall details
- Recall number
- Z-1231-2020
- Status
- Terminated
- Initiated by the company
- Dec 18, 2019
- Posted by the FDA
- Jan 24, 2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 824 units
- Product code
- JFY
- FDA submissions
- K070727
- Distribution
- US Nationwide
Product description
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Code information (models, lots, serial numbers)
UDI Number: 00630414595795 Lots: All lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica CH ECre_2 11097533Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall6 reports
Other devices under the same FDA submission
1 device cleared under K070727 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) 10335869Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall24 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84612).
- Z-1230-2020 · TerminatedADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
- Z-1232-2020 · TerminatedDimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
- Z-1233-2020 · TerminatedDimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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