Recall of Siemens Atellica CH A1c_E Devices for Potential Result Errors
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Siemens Healthcare Diagnostics is recalling 21,291 units of Atellica CH Enzymatic Hemoglobin A1c (A1c_E) due to potential for depressed test results that could delay diabetes diagnosis or treatment.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
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Recall of Siemens Atellica CH A1c_E Devices
What Happened
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) due to a potential for depressed results when processing on the same analyzer as Atellica CH RCRP. This issue can lead to negative bias and increased imprecision over time, which is not consistent with the assay's Instructions For Use (IFU), potentially causing delays in diabetes diagnosis or less-than-optimal treatment.
Which Products Are Affected
The affected product is Atellica CH Enzymatic Hemoglobin A1c (A1c_E) with Siemens Material Number (SMN): 11097536. The recall involves 21,291 units, including 9,750 in the US and 11,541 outside the US. Specific lot numbers include: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, and 150621. The UDI-DI is 00630414220505. Distribution was nationwide in the United States and internationally to countries including Argentina, Australia, and others.
What You Should Do
Consumers who have received a letter from Siemens Healthcare Diagnostics, Inc. regarding this recall should follow the instructions provided in that letter. For further information, contact the recalling firm at their address: 511 Benedict Ave, Tarrytown, NY 10591-5005.
Why This Matters
This recall addresses a potential issue that could lead to inaccurate diabetes test results, potentially delaying diagnosis or affecting treatment decisions for patients. It highlights the importance of reliable medical devices in healthcare to ensure patient safety and effective disease management.
Source
This information is from the FDA recall notice, recall number Z-1657-2026, available through the FDA's database (attribution: FDA, event ID 98498).
Original source: FDA Official Notice ↗
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