FDA recall, , Moderate risk
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., of Tarrytown, New York, began a recall on February 23, 2026, of the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) product. The recall was added to the FDA's Enforcement Report and classified on March 27, 2026, and in the FDA's weekly enforcement report on April 8, 2026.
The recall affects 21,291 units, with 9,750 distributed in the US and 11,541 outside the US, nationwide in the US and internationally in Argentina, Australia, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Curaçao, 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.
The agency stated that processing Atellica CH A1c_E and Atellica CH RCRP on the same analyzer may cause depressed results for A1c_E. Customers using separate analyzers for A1c_E and RCRP are not impacted. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU).
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
- UDI-DI
- 11097536
- 00630414220505
- Lot code
- 150131
- 150132
- 150232
- 150260
- 150283
- 150344
- 150361
- 150365
- 150366
- 150445
- 150453
- 150460
- 150498
- 150505
- 150562
- 150600
- 150618
- 150621
Recall details
- Company began the recall
- Sold in
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;
- Company
- Siemens Healthcare Diagnostics, Inc.Tarrytown, New York
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98498
- Recall number
- Z-1657-2026
- Quantity recalled
- 21,291 units (9750 US, 11541 OUS)
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
