The Recall Desk

Manufacturer

Cepheid

12 recalls in our database name Cepheid as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2025-12-24

Of the 12 recalls from Cepheid we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • HighFDA (Devices)·Z-0960-2026·2025-12-24

    Leukemia test kits recalled over inaccurate results with high white cell counts

    Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0959-2026·2025-12-24

    Leukemia test kits recalled in a second lot family over inaccurate results

    Cepheid is recalling 6,325 Xpert BCR-ABL Ultra kits, catalog GXBCRABL-US-10, because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0414-2026·2025-11-05

    Nasal test kits recalled after a false negative on a positive sample

    Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.

    Product
    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2024·2024-08-21

    Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk

    Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.

    Product
    Cepheid, Sample Collection Device, Part: 900-0370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.

    Product
    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.

    Product
    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2018·2018-02-21

    Cepheid Recalls Xpert CT/NG Tests Due to Temperature Drift Errors

    Cepheid is recalling specific batches of Xpert CT/NG tests due to reports of higher-than-expected temperature drift errors and an occasional probability of false negative results.

    Product
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0028-2018·2017-10-25

    Cepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results

    Cepheid is recalling Xpert EV Assay kits because customers reported a higher than expected number of invalid test results.

    Product
    Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individual
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2548-2016·2016-08-24

    Cepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues

    Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.

    Product
    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swab
    Category
    Medical Device
    Distribution
    24 states
  • LowFDA (Devices)·Z-2432-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.

    Product
    Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2431-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.

    Product
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DN
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cepheid

American molecular diagnostics company

Country
United States
Founded
1995

Official website

Source: Wikidata (Q15964713), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.