Beckman Coulter, Inc. recalls Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI)…
Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay…
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI)…
- Classification
- Class II
- Units
- Worldwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2025-02-12
USBeckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- US
Beckman Coulter Inc. recalls Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time…
FDA · DeviceBeckman Coulter Inc.Worldwide distribution - US Nationwide and the countries of Austria, Bahrain,…Official notice → - 2025-01-15
- US
Beckman Coulter, Inc. recalls Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid…
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues,…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2024-12-18
- US
Beckman Coulter Inc. recalls Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact…
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid…
FDA · DeviceBeckman Coulter Inc.Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil,…Official notice → - 2024-11-13
- US
Beckman Coulter, Inc. recalls The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels…
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot…
- 2024-11-06
- US
Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access…
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
FDA · DeviceBeckman Coulter, Inc.Distribution was made nationwide to the U.S., including Puerto Rico. There was…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-01
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Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained…
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain…Official notice → - US
Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
FDA · DeviceAbbott Vascular IncUS: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA,…Official notice → - US
O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the…
- US
MEDLINE INDUSTRIES, LP - Northfield recalls KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and…
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Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from…
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
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Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
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