The Recall Desk

FDA (Devices) recall action 71022

Siemens Medical Solutions Diagnostics recalled 6 products on 2015-06-03

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2015-06-03
Critical
0
Units
1,417

Why these products were recalled

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

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.

1–6 of 6

  • ModerateFDA (Devices)··2015-06-03

    Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Immulite 2000 Water Bottle Recall for Quality Defects

    Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings

    Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.

    Product
    Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems

    Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap from closing securely.

    Product
    Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Distribution
    0 states