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U.S. Department of Health and Human Services

Class 2 Device Recall DYNEX Agility

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  Class 2 Device Recall DYNEX Agility see related information
Date Initiated by Firm July 05, 2020
Create Date June 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-1222-2022
Recall Event ID 90099
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
Product DYNEX Agility, Agility Analyzer, Model No. 67000
Code Information UDI-DI: 05060456180058 Software version v1.4.3 Serial numbers: 1GXA0021 1GXA0022 1GXA0023 1GXA0024 1GXA0025 1GXA0026 1GXA0027 1GXA0028 1GXA0029 1GXA0030 1GXA0031 1GXA0032 1GXA0033 1GXA0034 1GXA0035 1GXA0036 1GXA0037 1GXA0038 1GXA0039 1GXA0040 1GXA0041 1GXA0042 1GXA0043 1GXA0044 1GXA0045 1GXA0046 1GXA0047 1GXA0048 1GXA0049 1GXA0050 1GXA0051 1GXA0052 1GXA0053 1GXA0054 1GXA0055 1GXA0056 1GXA0057 1GXA0058 1GXA0059 1GXA0060 1GXA0061 1GXA0062 1GXA0063 1GXA0064 1GXA0065 1GXA0066 1GXA0067 1GXA0068 1GXA0069 1GXA0070 1GXA0071 1GXA0072 1GXA0073 1GXA0074 1GXA0075 1GXA0076 1GXA0077 1GXA0078 1GXA0079 1GXA0080 1GXA0081 1GXA0082 1GXA0083 1GXA0084 1GXA0085 1GXA0086 1GXA0087 1GXA0088 1GXA0089 1GXA0090 1GXA0091 1GXA0092 1GXA0093 1GXA0094 1GXA0095 1GXA0096 1GXA0097 1GXA0098 1GXA0099 1GXA0100 1GXA0101 1GXA0102 1GXA0103 1GXA0104 1GXA0105 1GXA0106 1GXA0107 1GXA0108 1GXA0109 1GXA0110 1GXA0111 1GXA0112 1GXA0113 1GXA0114 1GXA0115 1GXA0116 1GXA0117 1GXA0118 1GXA0119 1GXA0120 1GXA0121 1GXA0122 1GXA0123 1GXA0124 1GXA0125 1GXA0126 1GXA0127 1GXA0128 1GXA0129 1GXA0130 1GXA0131 1GXA0132 1GXA0133 1GXA0134 1GXA0135 1GXA0136 1GXA0137 1GXA0138 1GXA0139 1GXA0140 1GXA0141 1GXA0142 1GXA0143 1GXA0144 1GXA0145 1GXA0146 1GXA0147 1GXA0148 1GXA0149 1GXA0150 1GXA0151 1GXA0152 1GXA0153 1GXA0154 1GXA0155 1GXA0156 1GXA0157 1GXA0158 1GXA0159 1GXA0160 1GXA0161 1GXA0162 1GXA0163 1GXA0164 1GXA0165 1GXA0166 1GXA0167 1GXA0168 1GXA0169 1GXA0170 1GXA0171 1GXA0172 1GXA0173 1GXA0174 1GXA0175 1GXA0176 1GXA0177 1GXA0178 1GXA0179 1GXA0180 1GXA0181 1GXA0182 1GXA0183 1GXA0184 1GXA0185 1GXA0186 1GXA0187 1GXA0188 1GXA0189 1GXA0190 1GXA0191 1GXA0192 1GXA0193 1GXA0194 1GXA0195 1GXA0196 1GXA0197 1GXA0198 1GXA0199 1GXA0200 1GXA0201 1GXA0202 1GXA0203 1GXA0204 1GXA0205 1GXA0206 1GXA0207 1GXA0208 1GXA0209 1GXA0210 1GXA0211 1GXA0212 1GXA0213 1GXA0214 1GXA0215 1GXA0216 1GXA0217 1GXA0218 1GXAB001 1GXAB002 1GXAB003 1GXAB004 1GXAB005 1GXAB006 1GXAB007 1GXAB008 1GXAB009 1GXAB010 1GXAB011 1GXAB012 1GXAB013 1GXAB014 1GXAB015 1GXAB016 1GXAB017 1GXAB018 1GXAB019 1GXAB020
Recalling Firm/
Manufacturer		 Dynex Technologies, Inc.
14340 Sullyfield Cir
Chantilly VA 20151-1621
For Additional Information Contact Jeff Fisher
703-803-1468
Manufacturer Reason
for Recall		 Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.
FDA Determined
Cause 2		 Software design
Action The firm first notified customers via mail and email between June and July 2020. Although only 17 units had been released with v1.4.3 installed, the firm notified all customers in possession of a device out of an abundance of caution. Customers were given workaround instructions to prevent the problem from occurring while the software was being corrected. Customers then received a follow up Field Safety Notice dated September 29, 2020. Distributors were asked to pass on the notification to any downstream customer accounts. The Agility software was updated to v1.4.7 to prevent controls and calibrators from sharing the same name. The update should prevent recurrence of the issue.
Quantity in Commerce 218 units (17 installed with v1.4.3)
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY, OH, PA, PR, TN, TX, UT, VA, WI, WV and the countries of Belgium, Brazil, China, Czech Republic, France, Germany, Mexico, Qatar, Romania, Russia, South Korea, Switzerland, Taiwan, and UK.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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