Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an
FDA device recall Z-1599-2020 · posted 2020-02-27 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
- Action taken
- On February 11, 2020, the firm issued an Urgent Medical Device Correction to all US customers. Customers who experience the issue were instructed to perform a pack calibration every 2 days or more frequently based on the laboratory's Quality Control performance. The firm is working to address the issue in a future software version. Customers are requested to complete and return the effectiveness check questionnaire. If you have any questions, contact your local Siemens Healthineers technical support representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DIC
- Quantity affected
- 1124
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Ital
- Date initiated
- 2020-02-14
- Date posted
- 2020-02-27
- Date terminated
- 2024-02-22
- 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 |
|---|---|---|
| ETOH FLEX REAGENT CARTRIDGE (DF22) (K071811) | Dade Behring, Inc. | 2007-08-24 |