FDA Device Recall Z-0023-2013: Biomerieux Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0023-2013.

Recall Res Number

Z-0023-2013

Recalling Firm / Manufacturer

Biomerieux Inc

FEI Number

1950204

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-08-28

Date Posted

2012-10-09

Date Terminated

2014-09-04

Product Code

LXG

Event Number

63019

Product Quantity

350 systems

Product Description 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.

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

Action Details 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.

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.

Code Information / Serial Numbers Serial numbers AS180-00001 to AS180-00376.

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Medical Device Recall: Z-0023-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer