BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures
Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.
What this means for you
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 involves a medical device where a manufacturing defect could lead to incorrect antibiotic treatment for Staphylococcus infections, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC-107, Catalog Number 448417, specifically Lot 7031818 with an expiration date of 2/28/2018. The product is an in vitro diagnostic (IVD) Gram positive AST Only panel used to test antibiotic susceptibility, specifically for the inducible macrolide-linosamide-streptogramin B (iMLSb) resistance D-test screen for Staphylococcus species.
The recall was initiated after the manufacturer confirmed quality control failures related to a manufacturing issue. The iMLSb test is used to identify phenotypic drug resistance to clindamycin and erythromycin. While the manufacturer states it is unlikely that patient results were impacted because the product should not be used when quality control fails, there is a potential risk if a customer did not perform QC testing and used the panel. In such cases, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result.
The affected units were distributed in the United States, with 7,750 units shipped to Connecticut, Virginia, Pennsylvania, Texas, Florida, North Carolina, Wisconsin, and New Mexico. The issue can be detected 100% of the time when the product is used per package insert instructions with the iMLSb positive strain S. aureus BAA-977.
The recalled product
- Product
- BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 7,750
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 7031818
- Exp. Date 2/28/2018
Distribution
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