Moderate riskFDA DeviceNov 6, 2026Class II

Siemens Atellica CH HDL reagent recalled for possible false test results

Reagent probe carryover on Siemens Atellica CH and Atellica CI analyzers may cause falsely elevated Hemoglobin A1c results and falsely depressed Direct Bilirubin 2 results. The problem may affect patient samples, quality control, and calibrator results. The recall covers all lots of the Atellica CH HDL Cholesterol (HDLC) reagent, Siemens Material Number 11537213, UDI-DI 00630414610832.

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

What to do

Identify all lots of Atellica CH HDL Cholesterol reagent, Siemens Material Number 11537213, UDI-DI 00630414610832, in your laboratory.
Contact Siemens Healthcare Diagnostics for instructions, since the notice does not specify a remedy.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Atellica CH HDL Cholesterol (HDLC); Siemens Material Number (SMN): 11537213;
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected: 72207 units (9744 US, 62463 OUS)
Illnesses reported: None reported
Manufactured in: 511 Benedict Ave, Tarrytown, New York, United States
Classification: Class II
Recall number: Z-0364-2027

In the FDA's words

Description: Atellica CH HDL Cholesterol (HDLC); Siemens Material Number (SMN): 11537213; 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. Siemens Material Number (SMN): 11537213; UDI-DI: 00630414610832; 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: 72207 units (9744 US, 62463 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; (this page)
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);
Z-0365-2027 · 25210 units (8087 US, 17123 OUS)