Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23920 |
| Brand Name: | cobas c111 Chemistry Analysers |
| Model: | All cobas c111 Chemistry Analysers (with and without ISE) |
| Affected: | |
| 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: | The results of an investigation show that a reagent carryover to CREP2 or to the Triglycerides test (TRIGL) might occur if a preceding test containing dextran sulfate (DS) (e.g. HDL-Cholesterol Gen.4 [HDLC4]) is pipetted first and is then followed by Cholesterol Gen.2 (CHOL2). The manufacturer requires the installation of extra wash cycles (EWCs) after CHOL2 as this prevents any observed high flyer results. Secondary carry-over to TRIGL or CRE2 occurs only if a dextran sulfate containing assay is performed before CHOL2. Hence these EWCs are only mandatory in case one of the following tests is also installed on the analyzer: HDLC4, HDLC3 or LDLC3. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/12/2018 |
