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FDA-Device2026-04-08Class IIPROCESSING DEFECT

Siemens Atellica CH A1c_E test kit recalled for potentially low results

Siemens
OTHERNationwide distribution

Check Siemens Atellica CH A1c_E test results

Siemens has recalled certain lots of its Atellica CH A1c_E hemoglobin test kit because when used with another reagent (RCRP) on the same analyzer, the A1c test may give lower-than-accurate results. Lower results could delay diabetes diagnosis or lead to inadequate treatment. This issue does not affect labs using separate analyzers for each test.

  • If you operate an Atellica CH analyzer using A1c_E and RCRP together, check your lot number against the affected list
  • Stop using affected lot numbers immediately
  • Contact Siemens for replacement reagents or further guidance
  • Review recent A1c test results from affected lots with your doctor if you have diabetes
Hazard

A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

Sold states
Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;
Affected count
21,291 units (9750 US, 11541 OUS)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1657-2026

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