Cepheid
Complete recall history across all FDA and CPSC categories — 12 total recalls
Cepheid appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (12)
FDA medical device enforcement actions by Cepheid
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Invitro diagnostic test kits with specimens that have elevated white blood ce... | Class II |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | Invitro diagnostic test kits with specimens that have elevated white blood ce... | Class II |
| Aug 6, 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000... | As a result of Post-Market half-time stability testing, false negative test r... | Class II |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been ... | Class II |
| Apr 24, 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | pipettes packaged in Strep A test may fail to dispense an adequate sample vol... | Class II |
| Apr 24, 2023 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | pipettes packaged in Strep A test may fail to dispense an adequate sample vol... | Class II |
| Oct 9, 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10... | Cepheid has received reports that some of our customers have experienced a hi... | Class II |
| Sep 15, 2017 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reve... | Customers have reported a higher than expected number of invalid test results... | Class II |
| Jul 18, 2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert... | Internal investigation found the certain lots of MRSA kits have the potential... | Class II |
| Jul 27, 2015 | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection ki... | Class III |
| Jul 27, 2015 | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection ki... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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