874 meters Software display error Lifescan 846

FastTake Compact Blood Glucose Monitoring System, used to quantitatively
measure glucose (sugar) levels in whole blood taken during home-care use,
under the following trade names:
One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S.
and Canada); PocketScan Compact Blood Glucose Monitoring System (in the
United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in
Europe); SmartScan Compact Blood Glucose Monitoring System (in Asia,
Middle East, Africa, Europe). Recall #Z-129-1.

The meter may display a “y” character instead of a number in the test

All meters with serial numbers starting with K, L, M and N.

Inverness Medical, Inc., Waltham, Massachusetts.
LifeScan, Inc., Milpitas, California, by letter on November 3, 2000.
Firm-initiated recall ongoing.
846,874 meters were distributed.

SoftwareCPR Keywords: IVD

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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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:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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