FDA Medical devices recall ·
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that… recall
- Recall number
- Z-0496-2025
- Date
- (initiated October 21, 2024)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave, Tarrytown, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9729 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # UDI N1527024 (01)00630414596143(10)N1527024(17)20291002; N1526424 (01)00630414596143(10)N1526424(17)20291001; N1525924 (01)00630414596143(10)N1525924(17)20290924 ; N1525324 (01)00630414596143(10)N1525324(17)20290918 ; N1524224 (01)00630414596143(10)N1524224(17)20290911; N1523724 (01)00630414596143(10)N1523724(17)20290904; N1523024 (01)00630414596143(10)N1523024(17)20290827; N1521824 (01)00630414596143(10)N1521824(17)20290814; N1521424 (01)00630414596143(10)N1521424(17)20290808; N1519324 (01)00630414596143(10)N1519324(17)20290719; N1518924 (01)00630414596143(10)N1518924(17)20290716; N1518224 (01)00630414596143(10)N1518224(17)20290710; N1518324 (01)00630414596143(10)N1518324(17)20290710; N1516224 (01)00630414596143(10)N1516224(17)20290621; N1515624 (01)00630414596143(10)N1515624(17)20290612; N1514924 (01)00630414596143(10)N1514924(17)20290605; N1514124 (01)00630414596143(10)N1514124(17)20290530; N1513324 (01)00630414596143(10)N1513324(17)20290522; N1512824 (01)00630414596143(10)N1512824(17)20290515; N1512424 (01)00630414596143(10)N1512424(17)20290510; N1511224 (01)00630414596143(10)N1511224(17)20290506; N1510724 (01)00630414596143(10)N1510724(17)20290423; N1510124 (01)00630414596143(10)N1510124(17)20290419.
Distribution
US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Libya Malaysia Mexico Moldova, Rep. of Morocco Nepal Netherlands Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0496-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.