Cepheid recalls
Cepheid appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2015-08-26 to 2025-12-24 |
| By agency | FDA Device (12) |
| By classification | Class II (10), Class III (2) |
| By status | ongoing (7), terminated (5) |
| Distribution named in notices | AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, US, VA, WA, WI |
Recalls
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid
Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid
Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. - Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
FDA Device · Class II · 2025-12-03 · Cepheid
Reason: Product testing did not meet expected stability criteria. - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid
Reason: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. - Cepheid, Sample Collection Device, Part: 900-0370
FDA Device · Class II · 2024-08-21 · Cepheid
Reason: 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… - Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Device · Class II · 2023-11-08 · Cepheid
Reason: 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. - Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD
FDA Device · Class II · 2023-11-08 · Cepheid
Reason: 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. - Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT…
FDA Device · Class II · 2018-02-21 · Cepheid
Reason: 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. Investigati… - Xpert EV Assay, Catalog GXEV-100N-10
FDA Device · Class II · 2017-10-25 · Cepheid
Reason: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. - Xpert MRSA Catalog GXMRSA-120, Rev
FDA Device · Class II · 2016-08-24 · Cepheid
Reason: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. - Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50
FDA Device · Class III · 2015-08-26 · Cepheid
Reason: 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. - Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50
FDA Device · Class III · 2015-08-26 · Cepheid
Reason: 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.