The Recall Desk

FDA (Devices) recall action 62505

Becton Dickinson & Co. recalled 5 products on 2012-09-12

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-09-12
Critical
0
Units
200

Why these products were recalled

Leakage in Cepheid SmartCycler reaction tubes.

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.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2012-09-12

    BD GeneOhm Cdiff Assay Recalled Due to Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay because of leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene…
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2012-09-12

    BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 68 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2012-09-12

    Becton Dickinson Recalls BD GeneOhm Cdiff Assay Due to Tube Leakage

    Becton Dickinson & Co. is recalling 32 kits of the BD GeneOhm Cdiff Assay because reaction tubes may leak. The product is distributed nationwide.

    Product
    BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C.…
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2012-09-12

    BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 38 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2012-09-12

    BD GeneOhm VanR Assay Recalled Due to Reaction Tube Leakage

    Becton Dickinson is recalling BD GeneOhm VanR Assay kits because reaction tubes may leak. The recall affects 5 kits distributed nationwide.

    Product
    BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance…
    Category
    Distribution
    23 states