PlainRecalls

Cepheid

Compiled from official public sources by the publisher.

12 recalls on record · Latest: Dec 24, 2025

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Agency notice ledger

Federal filing book Cepheid LIGHT-BOOK · SINGLE-AGENCY

#1,240 of 14,151 · 12 notices · 0.011% archive

  • BOOK 12 notices
  • RANK #1,240 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (12)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 24, 2025
  • PHOTO 2k Innovations Inc.

Nearest notice-volume peer: 2k Innovations Inc. (0 notice gap)

Cepheid accounts for about 0.011% of the 104,423-notice archive on 12 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Cepheid's standing among 14,151 recalling firms

Cepheid ranks 1,240th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Cepheid vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

12 1240th of 14151 higher than 12,841 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Cepheid in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Cepheid holds about 0.011% of archive notices alongside 12 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Dec 24, 2025

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Devices Moderate Dec 24, 2025

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Devices Moderate Dec 3, 2025

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA Devices Moderate Nov 5, 2025

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 methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
FDA Devices Moderate Aug 21, 2024

Cepheid, Sample Collection Device, Part: 900-0370
FDA Devices Moderate Nov 8, 2023

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
FDA Devices Moderate Nov 8, 2023

Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Devices Moderate Feb 21, 2018

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.
FDA Devices Moderate Oct 25, 2017

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 individuals with signs and symptoms of meningitis.
FDA Devices Moderate Aug 24, 2016

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 swabs in patients at risk for nasal colonization
FDA Devices Low Aug 26, 2015

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 DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
FDA Devices Low Aug 26, 2015

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 symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Cepheid holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

2k Innovations Inc. 12 Abbott Ireland Diagnostics Division 12 Agfa Healthcare Corp. 12 Boston Scientific 12

Frequently Asked Questions

How many federal recall notices name Cepheid? ▼
PlainRecalls indexes 12 distinct federal recall events naming Cepheid, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Cepheid sit among other recalling firms? ▼
Cepheid ranks #1,240 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Cepheid's notices? ▼
FDA Devices accounts for 12 of this firm's 12 indexed notices.
What product category dominates Cepheid's filing book? ▼
Filings for Cepheid span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Cepheid: 12 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Cepheid; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026