Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that… — Class II medical device recall Z-0496-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-11-27, distributed nationwide. A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packagi
| Recall number | Z-0496-2025 |
|---|---|
| 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 | 2024-10-21 |
| Classified | 2024-11-20 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LV, MA, MX, MY, NL, NO, NP, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 9,729 units |
| UPC / GTIN / UDI-DI | 00630414596143 |
| Lot numbers | N1510124, N1510724, N1511224, N1512424, N1512824, N1513324, N1514124, N1514924, N1515624, N1516224, N1518224, N1518324, N1518924, N1519324, N1521424, N1521824, N1523024, N1523724, N1524224, N1525324, N1525924, N1526424, N1527024 |
Product
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
Reason for recall
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
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-0496-2025. 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.