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

FDA device recall Z-2703-2026 · posted 2026-07-08 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PDJ

Quantity affected

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¿a

Date initiated

2026-06-08

Date posted

2026-07-08

Location

Tarrytown, NY

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