The Recall Desk

FDA (Devices) recall action 64228

Cellestis Inc recalled 2 products on 2013-03-06

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
2013-03-06
Critical
0
Units
339,090

Why these products were recalled

Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

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

  • HighFDA (Devices)··2013-03-06

    Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination

    Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 29,690 units distributed worldwide.

    Product
    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-03-06

    Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination

    Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 309,400 units distributed worldwide.

    Product
    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate
    Category
    Distribution
    0 states