Recall Z-0470-2016— Hardy Diagnostics
Class II · Terminated
Class II FDA medical device recall by Hardy Diagnostics, initiated 2015-11-18, terminated 2016-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.. Reason: The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination..
- Recalling firm
- Hardy Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-18
- Terminated
- 2016-03-28
- Firm location
- Santa Maria, CA, United States
Product description
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
Reason for recall
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.