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U.S. Department of Health and Human Services

Class 2 Device Recall PathoDx Strep B Grouping Latex

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  Class 2 Device Recall PathoDx Strep B Grouping Latex see related information
Date Initiated by Firm June 30, 2015
Date Posted August 07, 2015
Recall Status1 Terminated 3 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 2		 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.
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