Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0888-2013 — 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 heparinize

U.S. FDA — Device Enforcement · United States · 2012-09-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0888-2013
Date of alert: 2012-09-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cellestis Inc
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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