In the agency's Nov 18, 2026 enforcement report · Ongoing
Atellica CH HDL Cholesterol (HDLC); Siemens Material Number (SMN): 11537213;
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica CH HDL Cholesterol (HDLC)
- Siemens Material Number (SMN)11537213
- Lot codes and dates
- Siemens Material Number (SMN)11537213
- UDI-DI00630414610832; All lots
- Amount recalled
- 72207 units (9744 US, 62463 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Reagent probe carryover on the Atellica CH and Atellica CI Analyzers may cause falsely elevated Hemoglobin A1c (A1c_E/A1c_H) results due to HDLC carryover (biases of 9 29% in NGSP units), and falsely depressed Direct Bilirubin 2 (DBil_2) results due to TP_2 carryover (biases of 0% to -25%), which may affect patient samples, quality control, and/or calibrator results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Healthcare Diagnostics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.