25
Jan
2006

Instrumentation Laboratory Co. Class II

0

Company: Instrumentation Laboratory Co., Lexington, MA.
Date of Enforcement Report:1/25/2006
Class:lI

PRODUCT
GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06

REASON
Software error may report higher results for glucose and lactate.

CODE
Serial numbers starting with 18412

RECALLING FIRM/MANUFACTURER
nstrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2021 units

DISTRIBUTION
Nationwide and Canada

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.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

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