Recall Z-0309-2013— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2012-10-16, terminated 2013-10-28. FDA's recall record names no specific 510(k) clearance for this event. Product: bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.. Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-16
- Terminated
- 2013-10-28
- Firm location
- Hazelwood, MO, United States
Product description
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Reason for recall
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Data sourced from openFDA. This site is unofficial and independent of the FDA.