Beckman Coulter, Inc. recalls Access Substrate, REF 81906, For use with the Access Immunoassay Systems
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman…
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access Substrate, REF 81906, For use with the Access Immunoassay Systems
- Classification
- Class II
- Units
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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- 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
- 2024-07-31
USBeckman Coulter, Inc. recalls Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA,…Official notice →- 2024-07-10
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found…
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro…
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of Indiana and the…Official notice → - 2024-03-27
- US
Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2024-02-14
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2)…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Beckman Coulter, Inc. recalls Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2024-04-03
- US
DeRoyal Industries Inc recalls GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
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Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
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Olympus Corporation of the Americas recalls Insufflation unit, UHI-4.
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