VACUETTE Cellestis 1 ml QuantiFERON¿ — Class II medical device recall Z-0888-2013
Terminated recall by Cellestis Inc, reported 2013-03-06, distributed nationwide. Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due
| Recall number | Z-0888-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cellestis Inc, Santa Clarita, CA, United States |
| Recall initiated | 2012-09-27 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CH, CZ, DE, DK, EE, FI, FR, GB, IE, IL, JO, LU, MX, NL, NZ, PE, PL, SA, SI, SK, TR, ZA |
| Quantity | 309,400 units |
| Lot numbers | A111103N |
| Model numbers | 0592-0201, 454074 |
| Expiration dates | 2013-02-28 |
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 for recall
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0888-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.