Moderate riskFDA DeviceNov 6, 2026Class II

Siemens Atellica CH TP_2 reagent recalled for possible false A1c results

Reagent probe carryover on the Atellica CH and Atellica CI analyzers may cause falsely elevated Hemoglobin A1c results and falsely depressed Direct Bilirubin 2 results. These results may affect patient samples, quality control, and/or calibrator results. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Siemens recalls

What to do

Set aside affected Total Protein_2 (TP_2) reagent: SMN 11645755 (3700 tests, UDI-DI 00630414654010) and SMN 11537228 (7400 tests, UDI-DI 00630414611082), all lots.
Review A1c and Direct Bilirubin 2 results from the Atellica CH and CI analyzers that may have been affected.
The notice does not specify a remedy; contact Siemens Healthcare Diagnostics for next steps.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Atellica CH Total Protein_2 (TP_2); Siemens Material Number (SMN): 1. 11645755 (3700 tests), 2. 11537228 (7400 tests);
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 25210 units (8087 US, 17123 OUS)
Illnesses reported: None reported
Manufactured in: 511 Benedict Ave, Tarrytown, New York, United States
Classification: Class II
Recall number: Z-0365-2027

In the FDA's words

Description: Atellica CH Total Protein_2 (TP_2); Siemens Material Number (SMN): 1. 11645755 (3700 tests), 2. 11537228 (7400 tests); 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. 1. Siemens Material Number (SMN): 11645755 (3700 tests); UDI-DI: 00630414654010; All lots; 2. Siemens Material Number (SMN): 11537228 (7400 tests); UDI-DI: 00630414611082; All lots; Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cura¿ao, St Eus, Czech Republic, Democratic Republic Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Morocco, Nepal, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam. Affected quantity: 25210 units (8087 US, 17123 OUS)
Hazard: 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.

2 products in this recall

Siemens Atellica CH reagents recalled for possible false A1c results

Siemens is recalling two Atellica CH reagents: Atellica CH HDL Cholesterol (HDLC) and Atellica CH Total Protein_2 (TP_2). Reagent probe carryover on the Atellica CH and Atellica CI analyzers may cause falsely elevated Hemoglobin A1c results and falsely depressed Direct Bilirubin 2 results, which may affect patient samples, quality control, and calibrator results. No injuries have been reported, and the products were distributed in the US and many other countries.

The agency lists each product separately. Check every one you might have.

Atellica CH HDL Cholesterol (HDLC); Siemens Material Number (SMN): 11537213;
Z-0364-2027 · 72207 units (9744 US, 62463 OUS)
Atellica CH Total Protein_2 (TP_2); Siemens Material Number (SMN): 1. 11645755 (3700 tests), 2. 11537228 (7400 tests); (this page)
Z-0365-2027 · 25210 units (8087 US, 17123 OUS)