Reported Mar 6, 2013 · Terminated

Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one;…

Cellestis Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cellestis Inc · 28358 Constellation Rd Ste 698 · Santa Clarita, CA · 91355-5044

Is this the product you have?

  • 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 UsageQuantiFERON¿-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
Lot codes and dates
    • Cat # 0592-0501
    • Lot A111103M
    • Exp 28 FEB
    • 2013
Amount recalled
29,690 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 25, 2013 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.