Medical DeviceDec 24, 2025
Xpert BCR-ABL Ultra recall — FDA Z-0960-2026
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class IIFDA: OngoingCepheid
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceDec 24, 2025
Xpert BCR-ABL Ultra recall — FDA Z-0959-2026
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class IIFDA: OngoingCepheid
Understanding this recall history
This page summarizes recall records in which the official source identifies Cepheid as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.