Recall Z-1314-2016
Northeast Laboratory Services, Inc. · initiated December 21, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NEL- 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).
Codes / lots: Al lot codes
Reason for recall
Product marketed without a 510 (k)
FDA-determined cause: No Marketing Application
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.
Details
- Recall number
- Z-1314-2016
- Initiated
- December 21, 2015
- Posted by FDA
- April 1, 2016
- Terminated
- April 7, 2016
- Product code
- JSI – Culture Media, Selective And Differential
- Quantity
- 11720
- Distribution
- Nationwide Distribution.
- Recalling firm
- Northeast Laboratory Services, Inc., Winslow, ME
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1313-2016 Class II | NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the…Product marketed without a 510 (k) | 12/21/2015Terminated |