Class 2 Device Recall PathoDx Strep B Grouping Latex

• Date Initiated by Firm: June 30, 2015
• Date Posted: August 07, 2015
• Recall Status: Terminated on February 13, 2017
• Recall Number: Z-2351-2015
• Recall Event ID: 71614
• Product Classification: Antigens, all groups, streptococcus spp. - Product Code GTY
• Product: PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
• Code Information: lot 1463129, exp. date 31 May 2016
• Recalling Firm/ Manufacturer: Remel Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Gary L. Klaassen; 913-895-4077
• Manufacturer Reason for Recall: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
• FDA Determined Cause: Under Investigation by firm
• Action: On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.
• Quantity in Commerce: 4420 bottles
• Distribution: Nationwide Distribution, including Puerto Rico and the country of Canada.
• 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.