Z-1319-2008

DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp...

Name: Z-1319-2008 DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp...
Creator: BD Diagnostic Systems / Lee Laboratories
Published: 2007-08-08
License: https://open.fda.gov/license/

Lee Laboratories, Inc. / initiated 2007-08-08 / Terminated / root cause: manufacturing process

FDA source

BD Diagnostic Systems / Lee Laboratories began a recall of DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic on 2007-08-08. The reason FDA records is "Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1319-2008
Status: Terminated
Initiated: 2007-08-08
Posted: 2008-09-11
Terminated: 2009-03-24
Recalling firm: Lee Laboratories, Inc.
Product: DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
Product code: GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Reason for recall: Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 26 units
Distribution: Nationwide Distribution and Canada
Product codes and lots: Catalog number: 223181, Lot number: 6122656, Exp: 20090705.

Product code GTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)