Z-1657-2026Class II

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536

Name: Z-1657-2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-02-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-02-23 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536 on 2026-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1657-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-23
Posted: 2026-03-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Product code: PDJ Hemoglobin A1c Test System
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.
Root cause tag: manufacturing process
FDA 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 this letter within 30 days. Retain this letter with your laboratory records and forward it to others who may have received this product. Resolution A follow-up communication will be provided when Customer Actions are no longer required. We appreciate your continued partnership and apologize for any inconvenience this situation may cause. If you have any questions or require assistance, please contact your Siemens Healthineers Customer Care Center or your local technical support representative.
Quantity in commerce: 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 , 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;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1657-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1657-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code PDJ

K200256Class IIADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. / cleared 2021-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)