NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screen
FDA device recall Z-1313-2016 · posted 2016-04-01 · Terminated
Recall details
- Recalling firm
- Northeast Laboratory Services, Inc.
- Reason for recall
- Product marketed without a 510 (k)
- Action taken
- Northeast 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- JSI
- Quantity affected
- 9300
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-12-21
- Date posted
- 2016-04-01
- Date terminated
- 2016-04-07
- Location
- Winslow, ME
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