Reported May 2, 2018 · Terminated
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A…
Accelerate Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accelerate Diagnostics Inc · 3950 S Country Club Rd Ste 470 · Tucson, AZ · 85714-2240
Is this the product you have?
- 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.
- Lot codes and dates
Lot numbers 2880A2885A2886Aand 2887Aall with exp. date of 9/18/2018
- Amount recalled
- 95 kits
Where it was sold
Why it was recalled
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
This product could cause temporary or reversible health problems — stop using it.
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