Recall Z-1657-2026 · PDJ Hemoglobin A1c Test System
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
| Date | Mar 27, 2026 (initiated Feb 23, 2026) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process control |
| Action | On February 23, 2026 Urgent Medical Device Correction letters were sent to customers. Actions required: If your laboratory is not processing RCRP and A1c_E on the same analyzer, no action is required. If your laboratory is processing RCRP and A1c_E on the same analyzer, monitor A1c_E QC for evidence of negative bias and increased imprecision. Please review this letter with your Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to thi |
| Quantity | 21,291 units (9750 US, 11541 OUS) |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc., Jul 2, 2021 |