Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11...
Reason for Recall / 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.
Product Description & Identification
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Affected Products
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Additional Source Details
| Field | Value |
|---|---|
| City | Tarrytown |
| State | NY |
| Event id | 98498 |
| Address 1 | 511 Benedict Ave |
| Code info | Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621; |
| Postal code | 10591-5005 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 21,291 units (9750 US, 11541 OUS) |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260223 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic: 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;