DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro
FDA device recall Z-1319-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- BD Diagnostic Systems / Lee Laboratories
- Reason for recall
- Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
- Action taken
- Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GTQ
- Quantity affected
- 26 units
- Distribution
- Nationwide Distribution and Canada
- Date initiated
- 2007-08-08
- Date posted
- 2008-09-11
- Date terminated
- 2009-03-24
- Location
- Grayson, GA
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