Tegimenta Class II

Company: Tegimenta
Date of Enforcement Report: 10/17/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model
400, Catalog number 1045199.
All serial numbers of analyzers lower than 38-2606. Serial numbers of
38-2606 or higher have already been updated with software revision upgrade 4.

REASON:
If the operator fails to position the diluent on the instrument, the instrument may not detect that the reagent is missing an aspirate air instead of diluent.

MANUFACTURER:
Tegimenta, AB Switzerland,

RECALLED BY:
Roche Diagnostics Corp. Indianapolis, IN, by letter dated August 17, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
161 units

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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.