Recall Z-0889-2013— Cellestis Inc
Class II · Terminated
Class II FDA medical device recall by Cellestis Inc, initiated 2012-09-27, terminated 2013-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination..
- Recalling firm
- Cellestis Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-27
- Terminated
- 2013-04-25
- Firm location
- Santa Clarita, CA, United States
Product description
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.
Reason for recall
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.