Reported Oct 17, 2012 · Terminated
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation…
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers AS180-00001 to AS180-00376.
- Amount recalled
- 350 systems
Where it was sold
Why it was recalled
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
This product could cause temporary or reversible health problems — stop using it.
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