Z-0889-2013Class II

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

Name: Z-0889-2013 Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner...
Creator: Cellestis Inc
Published: 2012-09-27
License: https://open.fda.gov/license/

Cellestis Inc / initiated 2012-09-27 / Terminated / root cause: manufacturing process

FDA source

Cellestis Inc began a recall of 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... on 2012-09-27. FDA classified it as Class II and gives the reason as "Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0889-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-27
Posted: 2013-02-26
Terminated: 2013-04-25
Recalling firm: Cellestis Inc
Product: 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.
Product code: NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Reason for recall: Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.
Quantity in commerce: 29,690 units
Distribution: 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.
Product codes and lots: Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0889-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0888-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26
Z-0889-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code NCD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)