Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19796 |
| Brand Name: | Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000) |
| Model: | |
| Affected: | Part Nos: BR362571 and 04303413 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | There have been reports overseas that sample tubes may not be correctly placed back in the Rack Tube Transport (RTT) after the de-capping process. This may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. A false triggering or detection of the “READY” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. The system then continues with the next process step and opens the gripper prematurely. This issue may lead to contamination of the instrument and other samples. The risk to operator of contamination is less than remote. However, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/2/2016 |
