BD Phoenix diagnostic panel misformulated minocycline causes false resistance reporting
BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.
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: FDA Class II recall involving diagnostic error that could delay appropriate antibiotic treatment. Per the rubric, this is a risk-of-harm product where patient injury has not yet been reported, scoring High (3).
Plain-English summary
BD Becton Dickinson has recalled BD Phoenix PMIC/ID-107 diagnostic panels (Lot 1355046, expiration 31 January 2023) due to misformulation of minocycline in the test panels. Approximately 13,900 units were distributed nationwide in the United States.
The panels are used in clinical laboratories to rapidly identify bacteria and perform antimicrobial susceptibility testing. The misformulated minocycline causes the panel to report false resistance to minocycline, even when bacteria are susceptible to the drug. If a laboratory's quality control testing of the batch passes, the false results may go undetected and be reported to clinicians.
False resistance reporting could delay or prevent appropriate treatment with minocycline. Healthcare facilities and clinical laboratories that received affected units should immediately discontinue use of the affected lot and contact BD for instructions on appropriate corrective actions.
The recalled product
- Product
- BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 13,900
Distribution
Distributed nationwide across the United States.
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