CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report
Vacuette Cellestis QuantiFERON¿ TB Antigen recalled
Cellestis is recalling Vacuette Cellestis QuantiFERON¿ TB Antigen (HA) High Altitude: Shake 10x, distributed nationwide in the US. The recall was initiated on 27 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0889-2013
- FDA event ID
- 64228
- Recalling firm
- Cellestis, Santa Clarita, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2012
- FDA classified
- 26 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Sep 2012 | Recall initiated by company | |
| 26 Feb 2013 | Classified by FDA | +152 days |
| 6 Mar 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
Questions about this recall
Is Vacuette Cellestis QuantiFERON¿ TB Antigen (HA) High Altitude: Shake 10x recalled?
Yes. Cellestis recalled Vacuette Cellestis QuantiFERON¿ TB Antigen (HA) High Altitude: Shake 10x on 27 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0889-2013.
Why was it recalled?
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Which lots are affected?
Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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