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.
- Company
- Accelerate Diagnostics Inc
- Recall Initiated
- March 14, 2018
- Terminated
- January 17, 2023
- Recall Number
- Z-1529-2018
- Quantity
- 95 kits
- Firm Location
- Tucson, AZ
Reason for Recall
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Distribution
Distributed to IL, TX, CA, SC, and DE.
Lot / Code Info
Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
Root Cause
Under Investigation by firm
Action Taken
The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.