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[Recalled] 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. — The instrument may not dispe

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductPREVI 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.
Brand / manufacturerBiomerieux Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0023-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date28 August 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Biomerieux Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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