Z-2703-2026Class II

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536

Name: Z-2703-2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-06-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-06-08 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536 on 2026-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2703-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Product code: PDJ Hemoglobin A1c Test System
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Siemens Healthineers notified consignees on about 06/08/2026 via letter. Consignees were instructed to perform QC on each reagent well used for all A1c_E/A1c_H testing and enable "QC on Pack Change By Assay Type" to ensure QC is performed whenever testing transitions between wells. Enabling this setting will apply QC on Pack Change for all CH assays. If the lab uses Atellica CH to monitor QC, enable Patient QC Flagging to allow identification of potentially impacted patient results following a QC failure. Potentially impacted patient results will display a QC Fail flag and must be held from reporting and rerun after passing QC is obtained. If the lab uses Atellica Data Manager or other middleware to monitor QC, following a QC failure, hold all A1c_E/A1c_H samples processed after the failed QC event for review. Unload the reagent pack and load a new pack, repeat QC testing, and after acceptable QC results have been obtained, repeat any held A1c_E/A1c_H samples since the failed QC event. If repeated QC failures occur across consecutive wells, follow the lab s standard troubleshooting procedures to evaluate potential alternative causes for QC failure. Ensure to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Consignees were requested to complete and return the Field Correction Effectiveness Check Form, retain the letter with laboratory records and forward this letter to those who may have received this product, and as a result of these actions, track reagent inventory, associated with implementation of these actions, to report to Siemens Healthineers once a resolution is provided. A follow-up communication will be provided once the Customer Actions described above are no longer required. The follow-up communication will include an option for reporting A1c_E reagent inventory, including additional and/or discarded A1c_E/A1c_H tests or wells, to Sieme
Quantity in commerce: 24,077 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.
Product codes and lots: Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2703-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2703-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-08

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)