FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivat

FDA device recall Z-0470-2016 · posted 2015-12-23 · Terminated

Recall details

Recalling firm

Hardy Diagnostics

Reason for recall

The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JSC

Quantity affected

500 25pk/20)

Distribution

US. Distribution to the states of : CA, WI, MD and UT. .

Date initiated

2015-11-18

Date posted

2015-12-23

Date terminated

2016-03-28

Location

Santa Maria, CA