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Terminated

bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

FDA Recall Z-1177-2014 · Posted 2014-03-12

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLIB
Date Initiated2014-02-10
Date Terminated2017-03-16
Product Quantity471 instruments

Reason for Recall

The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.

Firm Action

The firm sent a recall notification letter to all of their consignees on 2/10/2014.

Root Cause

Software design

Distribution Pattern

Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.

Official Source

View FDA Recall →

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

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