The Recall Desk

FDA (Devices) recall action 65980

Assuramed recalled 3 products on 2013-09-25

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-09-25
Critical
0
Units
23

Why these products were recalled

The products may have been stored at temperatures outside their required storage conditions.

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

1–3 of 3

  • ModerateFDA (Devices)··2013-09-25

    Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues

    Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.

    Product
    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze…
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2013-09-25

    Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits

    Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.

    Product
    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and…
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2013-09-25

    Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues

    Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.

    Product
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.…
    Category
    Distribution
    18 states