Z-1313-2016 Class II Terminated
FDA device recall Z-1313-2016 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: 9300.
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
- 9300
Product Description
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; 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