Cepheid Recalls
12 recalls on record · August 26, 2015 to December 24, 2025 · Medical Devices
Recalls by year
15
16
17
18
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 24, 2025Medical DevicesFDA
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Hazard: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
December 24, 2025Medical DevicesFDA
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Hazard: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
December 3, 2025Medical DevicesFDA
Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Hazard: Product testing did not meet expected stability criteria.
November 5, 2025Medical DevicesFDA
Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes
Hazard: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
August 21, 2024Medical DevicesFDA
Cepheid recalls Cepheid, Sample Collection Device, Part: 900-0370
Hazard: 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 positive results for other specimens, and/or delay to test results.
November 8, 2023Medical DevicesFDA
Cepheid recalls Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Hazard: 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.
November 8, 2023Medical DevicesFDA
Cepheid recalls Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Hazard: 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.
February 21, 2018Medical DevicesFDA
Cepheid recalls Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 10000561
Hazard: 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 use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
October 25, 2017Medical DevicesFDA
Cepheid recalls Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction
Hazard: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
August 24, 2016Medical DevicesFDA
Cepheid recalls Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx S
Hazard: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
August 26, 2015Medical DevicesFDA
Cepheid recalls Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Coll
Hazard: Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
August 26, 2015Medical DevicesFDA
Cepheid recalls Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pe
Hazard: Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.