Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture…
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Read the official notice →- Date
- 2025-09-10
- Country
- United States
- Brand
- Bio-Rad Laboratories
- Product
- Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Bio-Rad Laboratories recalls
- 2024-04-03
US
Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
FDA · DeviceBio-Rad LaboratoriesUS Nationwide distribution in the states of PA, SD, TX, FL, MN.Official notice →- 2023-05-17
US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
FDA · DeviceBio-Rad Laboratories, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL,…Official notice →- 2023-04-19
US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
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 performing lot-to-lot validation against previous lots.…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Czech…Official notice →- 2022-12-07
US
Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
FDA · DeviceBio-Rad Laboratories, Inc.U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: NoneOfficial notice →- 2022-06-08
US
Bio-Rad Laboratories, Inc. recalls Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
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 Reorder Pack #250-3000. This CD-ROM software included in…
FDA · DeviceBio-Rad Laboratories, Inc.US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH,…Official notice →- 2022-05-25
US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2025-09-10
US
Merge Healthcare, Inc. recalls Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model…
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (…
FDA · DeviceMerge Healthcare, Inc.US Nationwide distribution including in the states of Arizona, Arkansas,…Official notice →US
Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalls FloPatch FP120, REF: FP120-FOT01-005
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
FDA · DeviceFlosonics Medical (R/A 1929803 ONTARIO CORP.)US Nationwide distribution in the state of California.Official notice →US
PREMIA SPINE LTD recalls TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Potential for missing pins at tip of inserter.
FDA · DevicePREMIA SPINE LTDUS Nationwide distribution in the state of Connecticut.Official notice →US
Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the…
FDA · DevicePreat CorpUS Nationwide distribution in the states of NY, FL, PA, CA, OH.Official notice →US
Medshape, INC. recalls Medshape Universal Joints, REF: DNE-9000-UJ
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
FDA · DeviceMedshape, INC.US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI,…Official notice →US
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…
Packaging failures were identified which could lead to a breach in the sterile barrier.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →