The Recall Desk

FDA (Devices) recall action 73325

Northeast Laboratory Services, Inc. recalled 2 products on 2016-04-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-04-13
Critical
0
Units
21,020

Why these products were recalled

Product marketed without a 510 (k)

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-04-13

    Northeast Laboratory Services Recalls GBS Medium Tubes for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 11,720 units of GBS Medium tubes because they were marketed without FDA 510(k) clearance.

    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).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-04-13

    Northeast Laboratory Services Recalls GBS Medium for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 9,300 units of GBS Medium because the product was marketed without FDA 510(k) clearance.

    Product
    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).
    Category
    Distribution
    0 states