Beckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure
Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin 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 involves a medical device with a confirmed quality control failure that could lead to inaccurate clinical test results (false elevated MICs), representing a risk of harm to patient care without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling MicroScan Pos MIC Panel Type 34, a medical device used to determine antimicrobial agent susceptibility and identify specific bacteria. The recall affects 685 panel boxes, totaling 13,700 panels, with the specific lot number 2021-06-10 and catalog number B1017-216.
The recall was initiated after a customer report and internal investigation confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin. This failure creates a possibility of obtaining false elevated Minimum Inhibitory Concentration (MIC) results for clinical isolates with daptomycin, even when quality control results are within specification.
The product was distributed nationwide in the United States, including in states such as Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, and Wisconsin. It was also distributed to numerous international countries. Healthcare facilities and laboratories should stop using the affected panels and contact Beckman Coulter for instructions on return or replacement.
The recalled product
- Product
- MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
- Manufacturer
- Beckman Coulter Inc.
Distribution
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