Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37602 |
| Brand Name: | LABScreen™ Mixed Class I & II |
| Model: | LABScreen™ Mixed Class I & II (Cat ID. LSM12, Lot 026) |
| Affected: | Multiple lots |
| Software version: | |
| Recalling Organisation: | Thermo Fisher Scientific New Zealand Ltd 244 Bush Road Albany AUCKLAND |
| Contact Information: | 0800 636 327 |
| Manufacturer: | One Lambda Inc |
| Issue: | The Data Sheets and Catalog Files associated with LABScreen Mixed Class I & II (Cat ID. LSM12, Lot 026) have the incorrect Cell ID and panel typing information for Bead ID 17. The correct information for Bead 17 is Cell ID C4966 (Panel Typing A2, B46, Bw6, Cw1) rather than Cell ID G0223 (Panel Typing A1, A11, B46, B57, Bw6, Bw4, Cw6, Cw8). There is no risk to patient or end user. The performance of the product to qualitatively detect HLA Class I antibody reactivity is not affected. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/9/2026 |
