Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25976 |
| Brand Name: | FluoroQuench™ |
| Model: | |
| Affected: | Catalog ID: FQAE100 Lot number: 047A Batch: 0000336132 Expiration Date:10/05/2020 and Catalog ID: FQAE500 Lot number: 047A Batch: 0000336129 Expiration Date: 10/06/2020 |
| Software version: | |
| Recalling Organisation: | Bio-Strategy Ltd 22a William Pickering Drive North Harbour Albany Auckland 0751 |
| Contact Information: | 09 969 9150 |
| Manufacturer: | One Lambda Inc |
| Issue: | FluoroQuench™ (Catalog ID FQAE100 and FQAE500) contains particles in the solution. These particles appear as specks in final imaging of the test result. There is low risk to patient or end user as a result of these particles. There is no impact to product as results can still be determined as positive or negative. Test results should be further investigated by the HLA specialist, as part of secondary and confirmatory testing as determined by ASHI and EFI guidelines. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/4/2020 |
