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U.S. Department of Health and Human Services

Class 2 Device Recall Accelerate PhenoTest BC kit

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  Class 2 Device Recall Accelerate PhenoTest BC kit see related information
Date Initiated by Firm March 14, 2018
Create Date April 26, 2018
Recall Status1 Terminated 3 on January 17, 2023
Recall Number Z-1529-2018
Recall Event ID 79631
Product Classification Positive blood culture identification and AST kit - Product Code PRH
Product 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.
Code Information Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
Recalling Firm/
Manufacturer		 Accelerate Diagnostics Inc
3950 S Country Club Rd Ste 470
Tucson AZ 85714-2240
For Additional Information Contact Pat Garland
520-609-8377
Manufacturer Reason
for Recall		 The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 95 kits
Distribution Distributed to IL, TX, CA, SC, and DE.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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