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U.S. Department of Health and Human Services

Class 2 Device Recall Accelerate Pheno system

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  Class 2 Device Recall Accelerate Pheno system see related information
Date Initiated by Firm March 13, 2017
Create Date March 27, 2019
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-1065-2019
Recall Event ID 82216
Product Classification Positive blood culture identification and AST kit - Product Code PRH
Product Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B

Product Usage:
The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.
Code Information REF: 10401008.  Serial Numbers:  1324, 1325, 1431, 1432, 1084, 1087, 1367, 1362,1363,1615, 1616, 1358, 1359, 1453, 1354, 1357, 1599, 1176, 1178, 1353, 1356, 1576, 1577, 1578, 1322, 1323, 1454, 1594, 1598, 1288, 1290, 1688, 1690, 1691, 1694, 1798, 1799, 1800, 1801, 1135, 1151, 1326, 1327, 1477, 1478, 1479, 1480, 1619, 1620, 1617, 1618, 1489, 1501, 1687, 1573, 1574, 1144, 1145, 1247, 1249 ,1264, 1277, 1265, 1277, 1278, 1381, 1150, 1286, 1148, 1149, 1254, 1260, 1397, 1542, 1458, 1517, 1231, 1238, 1282, 1284, 1389 
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		 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.
FDA Determined
Cause 2		 Software design
Action On 03/13/2017, customers were notified via phone of the potential risk of very major errors with meropenem for systems that have not been equipped with the most recent software update. TB000037, dated 03/16/17, was sent to customers after product launch. TB000082 and TB000083, dated 06/08/2018, were sent to customers that ran patient samples prior to installing the 1.3.1 PSW000012C patch. Starting on 01/25/19, Medical Device Correction notices were sent to customers, which provided a secondary notification of the suppression rules previously provided in TB000082 and TB000083. Customers were asked to do the following: (1) If you have not already done so, please contact customer support to schedule installation of the latest software version on your system. (2) Retrospectively review affected runs, specifically meropenem results. (3) As an interim measure, and until the latest software version is installed, you should review meropenem results obtained with the original software and apply the AST suppression rules (as noted in technical bulletins TB000082 and TB000083) to those results. Customers were asked to compete and return an acknowledgement form to indicate that they have received the correction notice and taken appropriate action. North America Customer Service and Technical Support: Toll free: +1 (888) 586 2939 opt. 4, Direct: +1 (520) 365 3100, Email: Support@axdx.com. EMEA Customer Service and Technical Support:: Direct: +34 93 220 4547, Email: Support.emea@axdx.com.
Quantity in Commerce 81
Distribution Worldwide Distribution - US Nationwide North America and Middle East US: TX, IL, TN, GA, CA, AR, MD, VA, Washington DC, IA, PA, NY, WA, and MO. OUS (Foreign): UK, Spain, Italy, and Germany
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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