Cobas® C 303
- Recalling firm
- Roche Diagnostics (NZ) Ltd
- Product
- cobas® c 303. [Device]. Affected: Multiple serial numbers
- Reason
- The manufacturer has received complaints where vacuum tubing of the cell rinse unit of the cobas® c 303 analytical unitprematurely deteriorated. Investigations confirmed the issue. In the event of small pinholes or cracks, no clearimpact on analytical performance was identified. However, in case of tubing rupture, the following can occur as aresult of the issue:, 1. Undetected leakage: Fluid may drip into random reaction cells., 2. Result impact: Increased risk of erroneous patient and QC results.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-24
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/4e3a6592-60db-436d-99e0-c2cad2bfd988