Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material… recallZ-2703-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 8, 2026

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number

Z-2703-2026

Status

Open, Classified

Initiated by the company

Jun 8, 2026

Posted by the FDA

Jul 8, 2026

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Quantity

24,077 units

Product code

PDJ

FDA submissions

K200256

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 description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Atellica CH A1c_E 11097536

  Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN
  3 recalls25 reports