Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results
Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.
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 that may produce incorrect diagnostic results (false-susceptible meropenem MIC) for rare bacterial isolates. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accelerate Diagnostics Inc is recalling 81 units of the Accelerate Pheno system, including software versions 1.2.1 through 1.3.1. The device is intended to measure signal intensity of fluorescent probes bound to nucleic acid and take time-lapse images of bacterial cells when used with Accelerate PhenoTest kits.
The recall is issued because rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device, whereas a resistant result is obtained by broth microdilution. To mitigate the risk associated with these rare isolates, the firm has implemented an Expert Rule in a software update that suppresses the meropenem result for isolates displaying a profile consistent with those that generated a false-susceptible result.
The affected units were distributed worldwide, including in the United States (TX, IL, TN, GA, CA, AR, MD, VA, Washington DC, IA, PA, NY, WA, and MO) and foreign countries (UK, Spain, Italy, and Germany). Users should contact the manufacturer to implement the software update that prevents incorrect results.
The recalled product
- Product
- Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse…
- Manufacturer
- Accelerate Diagnostics Inc
- Affected units
- 81
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)
- REF: 10401008. Serial Numbers: 1324
- 1325
- 1431
- 1432
- 1084
- 1087
- 1367
- 1362
- 1363
- 1615
- 1616
- 1358
- 1359
- 1453
- 1354
- 1357
- 1599
- 1176
- 1178
- 1353
Distribution
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