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 309,400 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. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk-of-harm product where injury has not yet been reported.
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, reference number 454074, with lot number A111103N and an expiration date of February 28, 2013.
The recall involves 309,400 units that were distributed worldwide, including the United States and various international markets such as Argentina, Australia, Austria, Belgium, and others. The product is an in vitro diagnostic test used to stimulate cells in heparinized whole blood using specific peptide cocktails.
Consumers and healthcare providers should stop using the affected blood collection tubes and contact Cellestis Inc for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Cellestis Inc
- Hazard
- Affected units
- 309,400
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 (3)
- Cat # 0592-0201
- Lot A111103N 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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