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.
- Company
- Hardy Diagnostics
- Recall Initiated
- November 18, 2015
- Posted
- December 23, 2015
- Terminated
- March 28, 2016
- Recall Number
- Z-0470-2016
- Quantity
- 500 25pk/20)
- Firm Location
- Santa Maria, CA
Reason for Recall
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Distribution
US. Distribution to the states of : CA, WI, MD and UT. .
Lot / Code Info
Cat. no. K31 Lot no.15231
Root Cause
Under Investigation by firm
Action Taken
Hardy Diagnostic notified Customers via phone on November 18, 2015, followed up with written notifications being sent via first class, email, or facsimile. Customers were instructed to destroy the recalled product according to local regulations for nonhazardous waste if uninoculated or as medical waste if inoculated. and to discard any remaining tubes of the recalled lot. Any remaining product on hand the firm stated would be replaced. The firm stated to customers that they would follow-up the phone conversation with written communication and requested a full name, and email or fax number. We sincerely apologize for the inconvenience. Thank you in advance for completing the attached form. Please feel free to contact our Technical Services Department if you have not received your replacements or if you have additional questions about this notification. Technical Services can be reached at (800) 266-2222, option 2 or via email at TechService@HardyDiagnostics.com.