Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
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 with false positive diagnostic results posing risk of clinical harm through misdiagnosis. No illnesses or injuries have been reported, but the defective FISH probes represent a risk-of-harm product affecting bacterial identification, a critical clinical function.
Plain-English summary
Accelerate Diagnostics Inc is recalling the Accelerate PhenoTest BC kit (REF 10101018), a diagnostic test containing fluorescence in situ hybridization (FISH) probes used for bacterial identification. The recall affects 200 kits with lot numbers 5549A, 5566A, 5588A, 5606A, and 5612A.
The recall was initiated due to an improperly formulated and released bulk lot of FISH probes. These defective probes may produce false positive results when identifying Staphylococcus aureus and Streptococcus species. False positive results could lead to incorrect clinical diagnoses and potentially inappropriate treatment decisions.
The affected kits have been distributed to healthcare facilities in 31 U.S. states (including Arkansas, California, Washington DC, Florida, and Georgia) and 10 countries outside the U.S. (Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates).
Healthcare providers who have used kits from the affected lots should review diagnostic results for Staphylococcus aureus and Streptococcus identification. Patients who received diagnoses based on these test results may need clinical follow-up to verify results. Facilities should contact Accelerate Diagnostics for instructions on returning affected kits.
The recalled product
- Product
- Accelerate PhenoTest BC kit REF 10101018
- Manufacturer
- Accelerate Diagnostics Inc
- Affected units
- 200
Distribution
Part of a larger recall action
This product is one of 2 recalled by Accelerate Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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