Atellica Ch Creatine Kinase
- Recalling firm
- Siemens Healthcare (NZ) Ltd
- Product
- Atellica CH Creatine Kinase. [Device]. Model: Serial number - 11097640. Affected: Lot numbers - 252591, 252602, 252612
- Reason
- The manufacturer has confirmed, through investigation of customer complaints, the potential for falsely elevated patient, quality control (QC), and/or calibrator results when using Atellica CH Creatine Kinase (CK_L) lot numbers 252591, 252602 and 252612 on the Atellica CH and Atellica CI Analyzers. This problem may be observed with both serum and plasma sample types. QC results may or may not detect the problem. the manufacturer is actively investigating the root cause of this problem.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-20
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/7340ece7-2ec6-4316-b36b-9d50cc6ea70e