PlainRecalls

Fujirebio Diagnostics, Inc.

Compiled from official public sources by the publisher.

7 recalls on record · Latest: Feb 11, 2026

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Agency notice ledger

Federal filing book Fujirebio Diagnostics, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,924 of 14,151 · 7 notices · 0.007% archive

  • BOOK 7 notices
  • RANK #1,924 of 14,151
  • SHARE 0.007% archive
  • AGENCY FDA Devices (7)
  • CAT medical devices
  • CATS 1 category
  • LATEST Feb 11, 2026
  • PHOTO A I Foods Corporation

Nearest notice-volume peer: A I Foods Corporation (0 notice gap)

Fujirebio Diagnostics, Inc. accounts for about 0.007% of the 104,423-notice archive on 7 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 →

How Fujirebio Diagnostics, Inc. compares to 14,151 recalling firms

Fujirebio Diagnostics, Inc. ranks 1,924th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Fujirebio Diagnostics, Inc. vs all firms by recall-notice count

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

7 1924th of 14151 higher than 12,091 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 · 2026-09-14

Fujirebio Diagnostics, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Fujirebio Diagnostics, Inc. holds about 0.007% of archive notices alongside 7 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected range
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1

FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions F
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expecte
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEI
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 ¿ 1.5 mL (4
FDA Devices Moderate Feb 11, 2026

Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step imm

Fujirebio Diagnostics, Inc. 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.

Abbott Diagnostics Scarborough, Inc. 7 Agfa N.v. 7 Alto Development Corp 7 Ambu Inc. 7

Frequently Asked Questions

How many federal recall notices name Fujirebio Diagnostics, Inc.? ▼
PlainRecalls indexes 7 distinct federal recall events naming Fujirebio Diagnostics, Inc., 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 Fujirebio Diagnostics, Inc. sit among other recalling firms? ▼
Fujirebio Diagnostics, Inc. ranks #1,924 of 14,151 by distinct recall-event count among 14,151 firms in this archive (85th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Fujirebio Diagnostics, Inc.'s notices? ▼
FDA Devices accounts for 7 of this firm's 7 indexed notices.
What product category dominates Fujirebio Diagnostics, Inc.'s filing book? ▼
Filings for Fujirebio Diagnostics, Inc. 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.
Fujirebio Diagnostics, Inc.: 7 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 Fujirebio Diagnostics, Inc.; individual notices remain authoritative on each linked recall page.

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