Recall Z-1304-2024 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
DCA Systems HbA1c Reagent Kit
| Date | Mar 19, 2024 (initiated Feb 7, 2024) |
| Status | Open, Classified |
| Reason | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter was sent to customers on 02/07/2024. Actions to be Taken by the Customer: Discontinue use of the reagent lots listed in Table 1. We are offering you the option to formally request a complimentary replacement product for discarded reagent kits through your local Siemens representative or authorized distributor by calling 877-885-4873. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. If the lot number you are using is not listed |
| Quantity | 74,211 Kits (Expanded 2/28/24: additional 72,892 kits) |
| Distribution | Worldwide distribution - US Nationwide and the country of Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951361 | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C Heraeus Kulzer, Inc., May 5, 1995 |