In the agency's Nov 18, 2026 enforcement report · Ongoing
Atellica CH Total Protein_2 (TP_2); Siemens Material Number (SMN): 1. 11645755 (3700 tests), 2. 11537228 (7400 tests);
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 Total Protein_2 (TP_2)
- Siemens Material Number (SMN)
1. 11645755 (3700 tests)2. 11537228 (7400 tests)
- Lot codes and dates
- 1
- Siemens Material Number (SMN)11645755 (3700 tests)
- UDI-DI
00630414654010All lots2
- Siemens Material Number (SMN)11537228 (7400 tests)
- UDI-DI00630414611082; All lots
- Amount recalled
- 25210 units (8087 US, 17123 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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