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.
Recall
- Recall Number
- Z-0470-2016
- Event Number
- 72786
- Firm
- Hardy Diagnostics
- FEI Number
- 2022807
- Product Code
- JSC
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- November 18, 2015
- Posted
- December 23, 2015
- Terminated
- March 28, 2016
- Address
- 1430 W McCoy Ln, Santa Maria, CA, 93455-1005
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.
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
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 [email protected].
US. Distribution to the states of : CA, WI, MD and UT. .
500 25pk/20)