Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accelerate Diagnostics Inc
- Reason for Recall:
- The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Product Codes/Lot Numbers:
Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
Distribution:
Distributed in: IL, TX, CA, SC, DE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1529-2018
Related Recalls
Accelerate PhenoTest BC kit REF 10101018
Accelerate Diagnostics
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
Accelerate PhenoTest BC kit REF 10102018
Accelerate Diagnostics
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.