PlainRecalls

Focus Diagnostics Inc

Compiled from official public sources by the publisher.

11 recalls on record · Latest: Apr 5, 2017

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Agency notice ledger

Federal filing book Focus Diagnostics Inc LIGHT-BOOK · SINGLE-AGENCY

#1,343 of 14,151 · 11 notices · 0.011% archive

  • BOOK 11 notices
  • RANK #1,343 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (11)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 5, 2017
  • PHOTO Agfa Corp.

Nearest notice-volume peer: Agfa Corp. (0 notice gap)

Focus Diagnostics Inc accounts for about 0.011% of the 104,423-notice archive on 11 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 →

Where Focus Diagnostics Inc sits among 14,151 recalling firms

Focus Diagnostics Inc ranks 1,343rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Focus Diagnostics Inc vs all firms by recall-notice count

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

11 1343rd of 14151 higher than 12,735 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 · 2026-09-16

Focus Diagnostics Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Focus Diagnostics Inc holds about 0.011% of archive notices alongside 11 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 5, 2017

Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Devices Moderate Apr 5, 2017

Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Devices Critical Apr 13, 2016

Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
FDA Devices Critical Apr 13, 2016

Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
FDA Devices Moderate Apr 13, 2016

Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
FDA Devices Moderate Nov 18, 2015

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
FDA Devices Moderate Apr 29, 2015

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
FDA Devices Moderate Jul 9, 2014

Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with cli
FDA Devices Moderate Mar 12, 2014

Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
FDA Devices Moderate Feb 5, 2014

Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is inten
FDA Devices Low Nov 7, 2012

West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of

Focus Diagnostics Inc holds a measurable archive slice

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (11 here — thin-book).

Agfa Corp. 11 Akron Pharma, Inc. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11 Arg Laboratories, Inc. 11

Similar medical devices volume

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

Agfa Corp. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11 Arjohuntleigh Polska Sp. z.o.o. 11

Frequently Asked Questions

How many federal recall notices name Focus Diagnostics Inc? ▼
PlainRecalls indexes 11 distinct federal recall events naming Focus 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 Focus Diagnostics Inc sit among other recalling firms? ▼
Focus Diagnostics Inc ranks #1,343 of 14,151 by distinct recall-event count among 14,151 firms in this archive (90th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Focus Diagnostics Inc's notices? ▼
FDA Devices accounts for 11 of this firm's 11 indexed notices.
What product category dominates Focus Diagnostics Inc's filing book? ▼
Filings for Focus 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.
Focus Diagnostics Inc: 11 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 Focus Diagnostics Inc; individual notices remain authoritative on each linked recall page.

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