DYNEX Agility, Agility Analyzer
Medical device recall Z-1222-2022. Published in FDA’s Enforcement Report on Jun 8, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 8, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 22 states named
- 218 units (17 installed with v1.4.3) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DYNEX Agility, Agility Analyzer, Model No. 67000
218 units (17 installed with v1.4.3), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,024 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
22 states and territories.
Every one of them
- Alabama
- California
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Massachusetts
- Maryland
- Michigan
- Nebraska
- New Jersey
- New York
- Ohio
- Pennsylvania
- Puerto Rico
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 5, 2020.
- FDA classified it on Jun 2, 2022.
- FDA’s Enforcement Report published it on Jun 8, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Dynex Technologies, Inc., of Chantilly, VA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,024 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.