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U.S. Department of Health and Human Services

Class 2 Device Recall Northeast Laboratory Services (NEL)

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 Class 2 Device Recall Northeast Laboratory Services (NEL)see related information
Date Initiated by FirmDecember 21, 2015
Date PostedApril 01, 2016
Recall Status1 Terminated 3 on April 07, 2016
Recall NumberZ-1314-2016
Recall Event ID 73325
Product Classification Culture media, selective and differential - Product Code JSI
ProductNEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Code Information Al lot codes
Recalling Firm/
Manufacturer		 Northeast Laboratory Services, Inc.
227 China Rd
Winslow ME 04901-0629
For Additional Information ContactSAME
800-244-9378
Manufacturer Reason
for Recall		Product marketed without a 510 (k)
FDA Determined
Cause 2		No Marketing Application
ActionNortheast Laboratory services issued recall letter dated 2/29/16 and advised users to: Immediately examine your inventory for all lots of these products you may have in stock. Please destroy all remaining product in stock. Users requested to fill out the questionnaire immediately and return the questionnaire via email or Fax. Previously Northeast Laboratory Services notified users by letter dated 12/21/15 that the firm has discontinued the products effective January 2016. Alternative products were referenced in the letter for users to transition to replacement product.
Quantity in Commerce11720
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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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