Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 29,690 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (contamination) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for potential harm without confirmed fatalities or Class I classification.
Plain-English summary
Cellestis Inc is recalling QuantiFERON-TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. The affected product is the Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude, identified by Cat # 0592-0501, Lot A111103M, with an expiration date of 28 FEB, 2013.
The recall involves 29,690 units. Distribution was worldwide, including the United States (nationwide) and numerous international locations such as Argentina, Australia, Austria, Belgium, and others. The product is an in vitro diagnostic test used to stimulate cells in heparinized whole blood.
Consumers and healthcare providers should stop using the affected blood collection tubes and contact the manufacturer or their supplier for further instructions.
The recalled product
- 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…
- Manufacturer
- Cellestis Inc
- Hazard
- Affected units
- 29,690
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Cat # 0592-0501
- Lot A111103M
- Exp 28 FEB
- 2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cellestis Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Cellestis Inc
See all →- HighCellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
FDA (Devices) · 2013-03-06
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