Drugs & medicalClass II

Beckman Coulter Inc. recalls Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover…

Read the official notice →
Date
2021-10-13
Country
United States
Brand
Beckman Coulter
Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Classification
Class II
Units
U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls

  1. 2022-05-25
  2. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283

    WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

    FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice →
  3. 2022-04-27
  4. US
    Drugs & medicalClass III

    Beckman Coulter, Inc. recalls Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    IRISpec CA failures for glucose.

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice →
  5. 2022-03-09
  6. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

    Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is…

    FDA · DeviceBeckman Coulter Inc.US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,…Official notice →
  7. 2021-12-29
  8. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

    Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in…

    FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of Louisiana, Ohio, North Carolina,…Official notice →
  9. 2021-10-20
  10. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

    Missing splash guard which may expose users to hazardous materials. .

    FDA · DeviceBeckman Coulter Inc.U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA,…Official notice →
  11. 2021-10-06
  12. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

    There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped…

    FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH,…Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2021-10-13
  2. US
    Drugs & medicalClass II

    CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

    Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

    FDA · DeviceCardioQuip, LLCWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
  3. US
    Drugs & medicalClass II

    Flower Orthopedics Corporation recalls Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

    FDA · DeviceFlower Orthopedics CorporationUS Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY,…Official notice →
  4. US
    Drugs & medicalClass III

    Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP…

    Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.

    FDA · DeviceSentinel CH SpAUS Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto…Official notice →
  5. US
    Drugs & medicalClass II

    NOX MEDICAL recalls Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    Error in the device firmware results in the inaccurate detection of device position.

    FDA · DeviceNOX MEDICALUS Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.Official notice →
  6. US
    Drugs & medicalClass II

    Contamac Solutions, Inc. recalls Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml…

    Contact lens solution may contain foreign material

    FDA · DeviceContamac Solutions, Inc.US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC,…Official notice →
  7. US
    Drugs & medicalClass I

    Aesthetics Systems Usa Inc recalls Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…

    FDA · DeviceAesthetics Systems Usa IncU.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.Official notice →
See all drugs & medical recalls →