Atellica CH Urinary/Cerebrospinal Fluid Protein — Class II medical device recall Z-0180-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2021-11-03, distributed nationwide. The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover imp
| Recall number | Z-0180-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2021-09-20 |
| Classified | 2021-10-28 |
| Reported by FDA | 2021-11-03 |
| Distributed | Nationwide (US) |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Reason for recall
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0180-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.