Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29218 |
| Brand Name: | Alinity m |
| Model: | regarding Alinity m EBV and Alinity CMV Amplification (AMP) Kits, List Numbers (LNs) 09N43-090 and 09N46-090, and the Alinity m EBV and Alinity CMV Application Specification Files (Whole Blood), LNs 09N43-03A and 09N46-03B utilized |
| Affected: | All |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Molecular Inc |
| Issue: | The manufacturer has identified a potential hazard of Incorrect Results, EBV and CMV in whole blood samples may be mis-quantitated/under-quantitated when processed using the Alinity m EBV Application Specification File (Whole Blood), LN 09N43-03A or the Alinity m CMV Application Specification File (Whole Blood), LN 09N46-03B. While there is potential impact to results for Alinity m EBV or Alinity m CMV, there is no impact or change to the assay reagents as the reagents may continue to be utilized with the Alinity m EBV Application Specification File (Plasma), LN 09N43-01A or Alinity m CMV Application Specification File (Plasma), LN 09N46-01A. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/4/2022 |
