Recall Z-3169-2024 · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Siemens Healthcare Diagnostics, Inc.
Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
| Date | Sep 18, 2024 (initiated Aug 15, 2024) |
| Status | Open, Classified |
| Reason | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare issued Urgent Medical Device Corrections (UMDC) to US consignees ACHC24-05.A.US, ACHC24-05.A.US.CHC on 8/15/24 via FedX and Urgent Field Safety Notices (UFSN)to foreign consignees ACHC24-05.A.OUS, ACHC24-05.A.OUS.CHC to affected customers informing them of the issue and the impact to results. ADVIA Chemistry customers are advised that lot 665399 meets the IFU prozone claim. Customers will be instructed to discontinue use of and discard the impacted reagent lots indicated in the letter. Atellica CH customers will be advised that lots 242194, 242195, and 242321 meet the IFU |
| Quantity | 18483 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.