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U.S. Department of Health and Human Services

Class 2 Device Recall FB Broth

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  Class 2 Device Recall FB Broth see related information
Date Initiated by Firm November 18, 2015
Date Posted December 23, 2015
Recall Status1 Terminated 3 on March 28, 2016
Recall Number Z-0470-2016
Recall Event ID 72786
Product Classification Culture media, general nutrient broth - Product Code JSC
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.

Code Information Cat. no. K31 Lot no.15231
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact
805-346-2766
Manufacturer Reason
for Recall		 The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 500 25pk/20)
Distribution US. Distribution to the states of : CA, WI, MD and UT. .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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