Reported Mar 19, 2014 · Terminated
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R),…
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?
- bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
- Lot codes and dates
- Serial number rangeAS 180-00001 to AS 180-00476
- Amount recalled
- 471 instruments
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Biomerieux Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.