BD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
Becton Dickinson is recalling 669,200 units of the BD Phoenix Panel NMIC-306 due to potential quality control failures with Klebsiella pneumoniae ATCC BAA-1705.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to potential quality control failures with Klebsiella pneumoniae ATCC BAA-1705. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Becton Dickinson & Co. is recalling 669,200 units of the BD Phoenix Panel NMIC-306, Catalog Number 449292. The recall was initiated due to a potential for quality control failures when using the CPO Ambler classification feature with Klebsiella pneumoniae ATCC BAA-1705.
The affected products were distributed nationwide in the United States. The recall includes specific lot numbers and UDI numbers listed in the agency's official records. This is a Class II recall, which indicates that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users of the product should contact Becton Dickinson & Co. for further instructions on how to proceed.
The recalled product
- Product
- BD Phoenix Panel NMIC-306. Catalog Number: 449292.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 669,200
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 (20)
- (10)5301046(17)26 1107(30)0025(01)3 0382904492923
- (10)5301019(17)26 1105(30)0025(01)3 0382904492923
- (10)5301058(17)26 1108(30)0025(01)3 0382904492923
- (10)5301088(17)26 1109(30)0025(01)3 0382904492923
- (10)5324448(17)26 1111(30)0025(01)3 0382904492923
- (10)5325592(17)26 1122(30)0025(01)3 0382904492923
- (10)5336528(17)26 1125(30)0025(01)3 0382904492923
- (10)5336554(17)26 1130(30)0025(01)3 0382904492923
- (10)5336667(17)26 1203(30)0025(01)3 0382904492923
- (10)5336716(17)26 1206(30)0025(01)3 0382904492923
- (10)5343520(17)26 1209(30)0025(01)3 0382904492923
- (10)5343522(17)26 1221(30)0025(01)3 0382904492923
- (10)5350942(17)26 1226(30)0025(01)3 0382904492923
- (10)5350876(17)26 1223(30)0025(01)3 0382904492923
- (10)5350972(17)26 1228(30)0025(01)3 0382904492923
- (10)6006439(17)26 1231(30)0025(01)3 0382904492923
- (10)6006497(17)27 0104(30)0025(01)3 0382904492923
- (10)6006475(17)27 0103(30)0025(01)3 0382904492923
- (10)6013345(17)27 0111(30)0025(01)3 0382904492923
- (10)6013300(17)27 0109(30)0025(01)3 0382904492923
Distribution
Distributed nationwide across the United States.
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