Coulter Class II (IVD) 1296 units

6/24/98 Beckman/Coulter Access Immunochemistry Set 81500 Software versions 3.22 and 3.23: Class II

1296 units. Sofware anomaly in these versions may allow test results to be posted to a different patient sample number. Recall #=Z-786/787-8.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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