Accelerate PhenoTest BC kit recall
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test…
Why was Accelerate PhenoTest BC kit recalled?
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
- Product
- Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test…
- Recalling firm
- Accelerate Diagnostics Inc
- Quantity
- 95 kits
- Distribution
- Distributed to IL, TX, CA, SC, and DE.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)