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: 7.
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
Medical DeviceNov 5, 2025
Cepheid Xpert SA Nasal Complete recall — FDA Z-0414-2026
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class IIFDA: OngoingCepheid
Medical DeviceAug 21, 2024
Cepheid recall — FDA Z-2584-2024
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false…
Class IIFDA: OngoingCepheid
Medical DeviceNov 8, 2023
Cepheid Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD recall — FDA Z-0216-2024
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Class IIFDA: OngoingCepheid
Medical DeviceNov 8, 2023
Cepheid Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only recall — FDA Z-0215-2024
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Class IIFDA: OngoingCepheid
Medical DeviceFeb 21, 2018
Cepheid Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch recall — FDA Z-0592-2018
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended…
Class IIFDA: TerminatedCepheid
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.