BD Vacutainer Citrate Blood Collection Tubes Recalled for Test Errors
Becton Dickinson is recalling specific blood collection tubes due to reports of extended Partial Thromboplastin Time (aPTT) test results.
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. The hazard involves potential diagnostic errors (extended aPTT results) which poses a risk of harm to patients through incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes, Reference 363083. The affected units are sterile, in vitro diagnostic (IVD) tubes measuring 13 x 75 mm with a volume of 2.7 mL. The recall involves Lot No. 2180434, which has an expiration date of April 2013.
The recall was initiated because of extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. This issue may affect the accuracy of laboratory testing performed using these specific tubes.
The affected products were distributed worldwide, including nationwide in the United States and in Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and the Virgin Islands. A total of 2,944,700 units are subject to this recall. Users should stop using the affected tubes and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 2,944,700
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 (2)
- Lot No. 2180434
- Expiration Date: April 2013
Distribution
Distributed nationwide across the United States.
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