Recall Z-0496-2025 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Nov 20, 2024 (initiated Oct 21, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens issued Urgent Medical Device Correction (UMDC) to l US affected customers via FedEx beginning on 10/21/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers beginning on 10/21/2024. In accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate c |
| Quantity | 9729 units |
| 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 Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics, Mar 9, 2017 |