Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Bio-Rad Laboratories medical devices: approvals, recalls and adverse events

Stock: BIO. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

458

De Novo: 1

PMA approvals

29 supplements

Recalled products

0 class I

Adverse event reports

1,686

3 deaths reported

How many recalls does Bio-Rad Laboratories have?

Bio-Rad Laboratories has 94 recalled medical device products in 71 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on May 30, 2025. In 2024 it had 1 recalled products.

How many medical devices has Bio-Rad Laboratories had cleared or approved?

458 510(k) clearances, 1 De Novo grants and 5 original PMA approvals for high-risk devices, plus 29 PMA supplements (changes to approved devices). The newest decision was on Apr 18, 2025.

How many adverse event reports name Bio-Rad Laboratories devices?

1,686 reports in total: 3 deaths, 19 injuries and 1,596 malfunctions were reported. 49 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2025	0	0	0	1
2019	2	0	0	0
2018	1	0	0	0
2017

Newest clearances and approvals

BioPlex 2200 Lyme Total
K183446 · 510(k) clearance · Mar 12, 2019
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
K181661 · 510(k) clearance · Feb 13, 2019
BioPlex 2200 25-OH Vitamin D Kit
K180577 · 510(k) clearance · Jun 22, 2018
MRSASelect II
K171061 · 510(k) clearance · Dec 28, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · 510(k) clearance · Sep 13, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
K170509 · 510(k) clearance · May 19, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
K170413 · 510(k) clearance · May 11, 2017
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · 510(k) clearance · Jan 10, 2017
D-10 Hemoglobin A1c Program
K161687 · 510(k) clearance · Oct 14, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
K152679 · 510(k) clearance · May 10, 2016

Devices with the most adverse event reports

By product code, all years

System, Test, Automated Blood Grouping And Antibody (KSZ, class 2)1,094
Blood Grouping Reagent (QHR, class U)237
Reagent Red Blood Cells (QHT, class U)101
Multi-Analyte Controls, All Kinds (Assayed) (JJY, class 1)38
Test, Hiv Detection (MZF, class 2)34
Anti-Human Globulin (QHS, class U)27
Kit, Quality Control For Blood Banking Reagents (KSF, class 2)25
Antinuclear Antibody, Antigen, Control (LKJ, class 2)19
Igg, Antigen, Antiserum, Control (DEW, class 2)15

All device makers and procedures · BIO stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to BIO with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	0	26	-
2025	1	49	-
2024	1	50	-
2023	3	77	-
2022	5	76	-
2021	2	95	-
2020	1	110	-
2019	3	84	-
2018	3	104	-
2017	0	112	-
2016	0	106	2
2015	3	68	-
2014	2	90	1
2013	3	125	-
2012	1	212	-

Newest recalls

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immu
Class II · May 30, 2025 · Due to a risk of false positive results that could lead to unnecessary medical treatment.
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Class II · Feb 15, 2024 · Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Class II · Feb 28, 2023 · APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Class II · Feb 21, 2023 · Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while per
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Class II · Feb 21, 2023 · Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while per
CMV IgM EIA, in vitro diagnostic.
Class II · Oct 19, 2022 · Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Class II · Apr 14, 2022 · Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Class II · Apr 7, 2022 · The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Class II · Feb 8, 2022 · Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent ma
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Class II · Feb 8, 2022 · Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent ma