Recall Z-2666-2023 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
| Date | Sep 30, 2023 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 8/8/23 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided in Additional Information. 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 loc |
| Quantity | 4966 reagents |
| Distribution | US Nationwide. Global Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.