30
May
2001

Instrumentation Laboratory Co. Class III

0

Company: Instrumentation Laboratory Co.

Date of Enforcement Report: 5/30/01

Class: III

PRODUCT:

ACL Futura Coagulation Analyzers. Recall #Z-577-1.

REASON:

There is a software error that may cause index file and record information to be
mismatched.

CODES:

All Serial Numbers with software version below V3.4.

MANUFACTURER:

Instrumentation Laboratory Co., Lexington, MA.

RECALLED BY:

Manufacturer, by letters, on February 12, 2001, March 30, 2001, and April 2,
2001. Firm-initiated recall ongoing.

DISTRIBUTION:

Nationwide

QUANTITY:

345.

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.

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