VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN recallZ-0888-2013 · Cellestis Inc · initiated Sep 27, 2012
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cellestis Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0888-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 27, 2012
- Posted by the FDA
- Feb 26, 2013
- Recalling firm
- Cellestis Inc
- Quantity
- 309,400 units
- Product code
- NCD
- FDA submissions
- P010033
- 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 description
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.
Code information (models, lots, serial numbers)
Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013
Other devices under the same FDA submission
2 devices cleared under P010033 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- QuantiFERON-TB Gold 2 Plate Kit 1Qiagen Sciences Inc. · Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis9 reports
- QuantiFERON®-TB Gold Plus 1Qiagen Sciences Inc. · Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 64228).
- Z-0889-2013 · TerminatedVacuette 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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