Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics Inc. is recalling the Atellica CH Enzymatic Hemoglobin A1c test reagent kits due to a confirmed potential for reagent carryover that could impact quality control results, patient samples, and calibrator results. The recall affects 6,606 units distributed globally and nationwide in the United States across 20 specific lot numbers.
The source document does not specify a remedy or recommended action for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Reason for recall: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. Distribution: Global Distribution. US Nationwide. Quantity: 6606 Lot/code info: UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.