Labscreen™ Mixed Class I & II
- Recalling firm
- Thermo Fisher Scientific New Zealand Ltd
- Product
- LABScreen™ Mixed Class I & II. [Device]. Model: LABScreen™ Mixed Class I & II (Cat ID. LSM12, Lot 026). Affected: Multiple lots
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-21
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/ffcbc6bc-000c-4ff8-87bc-8feacfe0c187