FDAFDA · Food and drugs·Recall number Z-0496-2025
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.
Published November 27, 2024 · Recall initiated: October 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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