VersaTREK Instrument Series 528 REF 6528 recalled over mold contamination

Recall date

May 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Remel Inc recalls VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recov…

Recall number

Z-1842-2015

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United King…

Why it was recalled

Use of the recalled product may result in false positive reports.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.