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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

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 Class 2 Device Recall Atellica CH Enzymatic Hemoglobin A1c (A1c_E)see related information
Date Initiated by FirmJune 08, 2026
Date PostedJuly 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2703-2026
Recall Event ID 99214
510(K)NumberK200256 
Product Classification Hemoglobin A1c test system - Product Code PDJ
ProductAtellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Code Information Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSiemens Healthineers Customer Care Center
877-229-3711
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionSiemens 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 Commerce24,077 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PDJ
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