Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Class I recall

This article was originally published in The Gray Sheet

Executive Summary

BioMerieux's VeriCal calibrator set recall has been designated Class I by FDA. The French company initiated the action in August because units are mislabeled and "could result in misdiagnosis or injury to patients, serious illness or death from erroneous calibration data leading to use of improper levels of oral anticoagulant drugs," the firm says. The in vitro diagnostic device, which has been distributed worldwide - including to 437 customers in the U.S. - is used to calibrate prothrombin time and activated partial thromboplastin time for coagulation assays. BioMerieux was involved in another Class I recall in March related to the mislabeling of MDA Simplastin human thromboplastin factor tissue reagents. The firm received warning letters from FDA in July 2004 and July 2005 citing quality system lapses at its Durham, N.C. manufacturing plant (1"The Gray Sheet" Aug. 30, 2004, p. 26)...

You may also be interested in...

bioMerieux Exploring QS Improvements Following IVD Facility Inspections

bioMerieux is bringing in consultants to help resolve quality system issues identified by FDA after an April inspection of the firm's Durham, N.C. facility, the firm reported in a recent earnings release

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts