Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Numbe
See all recalls from Siemens Healthcare Diagnostics, Inc. →Recalled Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Hazard / Issue
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Atellica CH Enzymatic Hemoglobin →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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