Atellica Ch Revised C-reactive Protein (rcrp)
- Recalling firm
- Siemens Healthcare (NZ) Ltd
- Product
- Atellica CH Revised C-Reactive Protein (RCRP). [Device]. Affected: All Lots
- Reason
- The manufacturer has confirmed through the investigation of customer complaints the potential for falsely elevated results when the Atellica CH Revised C-Reactive Protein (RCRP) assay is used on the Atellica CH and Atellica CI analyzers. A small subset of samples may reproducibly generate one of the following outcomes:, 1. A falsely elevated, reportable result., 2. An initial falsely elevated result above the measuring interval (>25.00 mg/dL or >250.0 mg/L), followed by a 5X auto-diluted result that is inconsistent with the initial result. In this scenario, the auto-diluted result is...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-28
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/2a19b8fb-de5c-47b6-b9f3-1f98275c8903