FDA Device recall Z-0888-2013
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN by Cellestis, citing cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0888-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-27 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cellestis |
| Distribution | US |
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 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.
Identifiers
| code_info | Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0888-2013%22
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