Siemens Healthcare recalls DCA HbA1c Reagent Kits with potential for incorrect glucose test results due to positive bias. Affected lots may lead to improper diabetes management. Contact for remedy details.
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%.
Siemens Healthcare is recalling DCA HbA1c Reagent Kits that may display a positive bias without alerting users, potentially causing incorrect glucose test results. This could lead to improper diabetes management if the test results are used for patient care.
The reagent kit may show a positive bias (up to 19% higher than true value) without warning. This could cause test results to be too high, leading to incorrect diabetes management decisions.
Diabetes patients using the DCA HbA1c Reagent Kit for glucose monitoring may be affected. Those using the specific lots listed in the recall are most at risk.
Check for the Siemens Material Number 10311134 and UDI/DI 00630414532806. Affected lots include 9640093, 0645103, 0648103, 0649103, 0654103 and expanded lots through 02/28/2024.
Look for the lot numbers listed in the recall: 9640093, 0645103, 0648103, 0649103, 0654103, and expanded lots through 02/28/2024.
The DCA HbA1c Reagent Kit may display a positive bias without alerting users, potentially causing incorrect glucose test results and improper diabetes management.
The kit may show test results up to 19% higher than true value, which could lead to incorrect diabetes management decisions.
Check for the Siemens Material Number 10311134 and UDI/DI 00630414532806. Affected lots include 9640093, 0645103, 0648103, 0649103, 0654103 and expanded lots through 02/28/2024.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1304-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1304-2024 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
