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.
Read the official notice →- Date
- 2023-05-17
- Country
- United States
- Brand
- Bio-Rad Laboratories
- Product
- BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-09-10
US
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.
FDA · DeviceBio-Rad Laboratories, Inc.U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.Official notice →- 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 →- 2023-04-19
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
- 2023-05-17
US
Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the…
FDA · DeviceDiagnostica Stago, Inc.US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.Official notice →US
Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal…
Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
US
Technidata S.A. recalls TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology,…
In a specific use case, when printing labels for slides, some labels may display wrong information
US
Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft…
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
FDA · DeviceEthicon, Inc.International distribution in the countries of United Kingdom, Ireland and…Official notice →US
New Wave Endo-Surgical, Corp. recalls M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
The plastic housing on the device may fracture
FDA · DeviceNew Wave Endo-Surgical, Corp.US Nationwide distribution in the states of FL, MA, and GA.Official notice →US
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during…
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the state of OH.Official notice →