Recall Z-0929-2022 ยท PDJ Hemoglobin A1c Test System
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
| Date | Feb 9, 2022 |
| Status | Open, Classified |
| Reason | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction notification letters dated 2/9/22 were sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director. Perform the instructions provided in the Additional Information section below. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical |
| Quantity | 6606 |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay Siemens Healthcare Diagnostics, Inc., Dec 4, 2017 |