Z-1314-2016 Class II Terminated
FDA device recall Z-1314-2016 was initiated by Northeast Laboratory Services, Inc. on December 21, 2015 and is designated Class II. Reason for recall: Product marketed without a 510 (k) The recall status is terminated (terminated April 7, 2016). Affected quantity: 11720.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- December 21, 2015
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11720
Product Description
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).
Reason for Recall
Product marketed without a 510 (k)
Distribution Pattern
Nationwide Distribution.
Code Information
Al lot codes