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Terminated

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

FDA Recall Z-0023-2013 · Posted 2012-10-09

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLXG
Date Initiated2012-08-28
Date Terminated2014-09-04
Product Quantity350 systems

Reason for Recall

The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

Firm Action

bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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