Lower risk Medical device recall · FDA · Published February 7, 2024

Siemens DCA HbA1c Reagent Kit Recall: Erroneous Glucose Test Results Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1304-2024Medical device Siemens Healthcare ›

Lower-risk recall

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%.

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.511 Benedict Ave · Tarrytown, NY 10591-5005

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/56186-siemens-dca-hba1c-reagent-kit-recall-erroneous-glucose-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/56186-siemens-dca-hba1c-reagent-kit-recall-erroneous-glucose-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1304-2024

Cite this page

“Siemens DCA HbA1c Reagent Kit Recall: Erroneous Glucose Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56186-siemens-dca-hba1c-reagent-kit-recall-erroneous-glucose-test-results. Based on FDA recall #Z-1304-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2024%22&limit=1).

The FDA announced on Feb. 7, 2024, that Siemens Healthcare Diagnostics is recalling DCA Systems HbA1c Reagent Kits due to a positive bias in test results. This defect may lead to incorrect patient management of glucose control.

How to tell if you have it

Brand: Siemens Healthcare
Product: DCA Systems HbA1c Reagent Kit
Siemens Material Number: 10311134
UDI/DI: 00630414532806
Lot codes: 9640093, 0645103, 0648103, 0649103, 0654103, 0637093, 0641093, 0642093, 0647103, 0653103, 0655103
Distribution: US Nationwide and Taiwan

The hazard

The recalled kits display a positive bias without alerting the user. The maximum bias observed was 19% when compared to NGSP pooled patient target-value assigned samples. Erroneous test results could potentially lead to incorrect patient management of glucose control.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics has 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test recall from Aug. 17, 2026, and the Beckman Coulter Emit 2000 Quinidine Assay Recall from July 13, 2026. Similar product recalls include the Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall from Nov. 24, 2025.

How to tell if you have this one

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.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for the lot numbers listed in the recall: 9640093, 0645103, 0648103, 0649103, 0654103, and expanded lots through 02/28/2024.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the country of Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

Feb 7, 2024Firm started the recall
Mar 19, 2024FDA classified it Class II
Mar 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Siemens Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/56186-siemens-dca-hba1c-reagent-kit-recall-erroneous-glucose-test-results">Siemens DCA HbA1c Reagent Kit Recall: Erroneous Glucose Test Results Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1304-2024 (February 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1304-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.