Drugs & medicalClass II

Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

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 manufacturing challenges to produce RPR reagents that…

Read the official notice →
Date
2022-03-23
Country
United States
Brand
Bio-Rad Laboratories
Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Classification
Class II
Units
Worldwide distribution U.S. Nationwide distribution in the states of AK, AL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2023-04-19
  2. US
    Drugs & medicalClass II

    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 →
  3. 2022-12-07
  4. US
    Drugs & medicalClass II

    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 →
  5. 2022-06-08
  6. US
    Drugs & medicalClass II

    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 →
  7. 2022-05-25
  8. US
    Drugs & medicalClass II

    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 →
  9. 2021-11-24
  10. US
    Drugs & medicalClass II

    Bio-Rad Laboratories, Inc. recalls BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is…

    Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation…

    FDA · DeviceBio-Rad Laboratories, Inc.Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA,…Official notice →
  11. 2021-10-20
  12. US
    Drugs & medicalClass II

    Bio-Rad Laboratories, Inc. recalls BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen…

    A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.

    FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S Nationwide distribution including in the states…Official notice →
All 10 Bio-Rad Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2022-03-30
  2. US
    Drugs & medicalClass II

    Teligent Pharma, Inc. recalls Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC…

    cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

    FDA · DrugTeligent Pharma, Inc.Nationwide in the USA and Puerto RicoOfficial notice →
  3. US
    Drugs & medicalClass I

    Blaine Labs Inc recalls REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ)…

    Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

    FDA · DrugBlaine Labs IncNationwide in 17 States to 45 doctors.Official notice →
  4. 2022-03-23
  5. US
    Drugs & medicalClass II

    GE Healthcare, LLC recalls GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

    If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

    FDA · DeviceGE Healthcare, LLCWorldwide distribution - US nationwide, including Puerto Rico. There was also…Official notice →
  6. US
    Drugs & medicalClass III

    CellEra LLC recalls 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

    Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the…

    FDA · DeviceCellEra LLCUS Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Bard Peripheral Vascular Inc recalls LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

    Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

    FDA · DeviceBard Peripheral Vascular IncU.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA,…Official notice →
  8. US
    Drugs & medicalClass II

    Sam Medical Products recalls SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

    Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an…

    FDA · DeviceSam Medical ProductsU.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA…Official notice →
See all drugs & medical recalls →