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…
Read the official notice →- Date
- 2024-11-13
- Country
- United States
- Brand
- Beckman Coulter
- Product
- The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels…
- Classification
- Class II
- Units
- Worldwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-15
USBeckman 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 →- 2025-01-01
- US
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…
- 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 → - 2024-11-06
- 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 → - 2024-10-23
- US
Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry…
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
FDA · DeviceBeckman Coulter Inc.U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.:…Official notice → - US
Beckman Coulter, Inc. recalls The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human…
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →
Other drugs & medical recalls in the United States
- 2024-11-13
- US
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic…
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or…
FDA · DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONUS Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE,…Official notice → - US
Biocare Medical, LLC recalls intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen,…
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test…
FDA · DeviceBiocare Medical, LLCUS Nationwide distribution in the states of MA, AZ, CT, NY, FL, NC, IN, IL,…Official notice → - US
Nihon Kohden America Inc recalls Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who…
Due to products being shipped/distributed to customers after the products expiration date had past.
FDA · DeviceNihon Kohden America IncU.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR,…Official notice → - US
Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
There is discrepant labeling on the inner and outer packaging of the device.
FDA · DeviceDatascope Corp.International distribution to the countries of Germany, Spain , Finland, Great…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual…
- US
Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA · DeviceMedtronic Perfusion SystemsUS: NY, OH, IL, NJ, MI, TN, WI, Australia, and SingaporeOfficial notice →