Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21610 |
| Brand Name: | AllSet = Gold SSP |
| Model: | |
| Affected: | Lots 54340D (Lot 038), 54030D (Lot 005), 54330D (Lot 021) |
| Software version: | |
| Recalling Organisation: | Bio-Strategy Ltd 22a William Pickering Drive North Harbour Albany Auckland 0751 |
| Contact Information: | 09 969 9150 |
| Manufacturer: | Thermo Fisher Scientific Australia Pty Ltd |
| Issue: | The manufacturer is aware of the AllSet+ Gold SSP kits. The primers PM074D and C15-02A should be negative for the following alleles: :, B*07:219, B*57:02:01, , B*57:02:02, , B*57:03:02, , B*57:07, B*57:09, B*57:12, B*57:17, B*57:28N, B*57:39, B*57:42, B*57:46, B*57:57, B*57:63, B*57:66, B*57:70, B*57:80, B*57:82, B*58:08:01, B*58:08:02, B*58:20, B*58:27, B*58:28:01, B*58:28:02, B*58:65, and B*58:73 during analysis. The Lot specific user documents and software UCH files contain the incorrect allele specificity information for these two primer mixes. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/7/2017 |
