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Recall Observatory FDA recall evidence

Device 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 TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.

Z-0889-2013

September 27, 2012

Class II

Product summary

Firm
Cellestis Inc
Event
Event 64228
Status
Terminated
Classification
Class II
Quantity
29,690 units
Official record key
device-enforcement:Z-0889-2013

Official wording

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

Code information: Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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