Atellica Ch And Atellica Ci Analysers
- Recalling firm
- Siemens Healthcare (NZ) Ltd
- Product
- Atellica CH and Atellica CI Analysers. [Device]. Model: Atellica CH HDL Cholesterol (HDLC) and Atellica CH Total Protein_2 (TP_2). Affected: Material Number - 11537213 and 11537228 All Lots
- Reason
- The manufacturer has confirmed via complaints the potential for reagent carryover on the Atellica CH and Atellica CI Analysers. If carryover occurs, it may affect patient samples, quality control (QC), and/or calibrator results., For the Atellica CH Analyzer:, · Carryover from Atellica CH HDL Cholesterol (HDLC) may cause falsely elevated Atellica CH Enzymatic Haemoglobin A1c (A1c_E, A1c_H) results., For the Atellica CI Analyzer:, · Carryover from Atellica CH HDL Cholesterol (HDLC) may cause falsely elevated Atellica CH Enzymatic Haemoglobin A1c (A1c_E) results., · Carryover from Atellica...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/48f64e2d-9300-4960-b87e-c423236a96b6