Siemens Atellica CH Enzymatic Hemoglobin A1c Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics, Inc. is recalling 24,077 units of Atellica CH Enzymatic Hemoglobin A1c (A1c_E) due to potential assay bias causing incorrect HbA1c results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall due to 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.
Which Products Are Affected
- Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
- Material Number: 11097536
- UDI-DI: 00630414220505
- All Lot Numbers
- Quantity: 24,077 units
- Distribution: US Nationwide and worldwide including Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Croatia, Curaçao, 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, and Vietnam.
- Recall Number: Z-2703-2026
- Classification: Class II
What You Should Do
The recalling firm, Siemens Healthcare Diagnostics, Inc., initiated the recall via letter. Affected units were distributed from the firm's address at 511 Benedict Ave, Tarrytown, NY 10591-5005.
Why This Matters
The recall involves 24,077 units distributed worldwide and may impact HbA1c patient test results.
Source
FDA recall Z-2703-2026, event ID 99214. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,699 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.