Diagnostic Kit Recalled for False Positive Bacterial Identification Results
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.
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: FDA Class II recall. The hazard is false positive diagnostic results that pose risk of harm through potential misdiagnosis and inappropriate treatment. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, per the rubric criterion for score 3.
Plain-English summary
The Accelerate PhenoTest BC kit REF 10102018, a diagnostic device used in clinical laboratories to identify bacteria, is being recalled. The recall is due to improperly formulated and released bulk lots of fluorescence in situ hybridization (FISH) probes that can produce false positive identification results for Staphylococcus aureus and Streptococcus species.
Approximately 7,160 kits with 50 specific affected lot numbers have been distributed to clinical laboratories across the United States (35 states plus Washington D.C.) and internationally to Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates. Healthcare providers and laboratories should refer to the FDA recall notice for the complete list of affected lot numbers, which includes lots 5559A, 5556A, 5555A, and others.
The recalled product
- Product
- Accelerate PhenoTest BC kit REF 10102018
- Manufacturer
- Accelerate Diagnostics Inc
- Affected units
- 7,160
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
Same manufacturer · Accelerate Diagnostics Inc
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