FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and…
Medical device recall Z-0361-2019. Published in FDA’s Enforcement Report on Nov 7, 2018.
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 Nov 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 679 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?
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87”) from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
679, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FLX.011 FLX.009 FLX.010 FLX.012 FLX.014 FLX.015 FLX.017 FLX.018 FLX.016 FLX.019 FLX.020 FLX.021 FLX.022 FLX.023 FLX.025 FLX.027…
Every code shown here, 1,999 characters
FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FLX.011 FLX.009 FLX.010 FLX.012 FLX.014 FLX.015 FLX.017 FLX.018 FLX.016 FLX.019 FLX.020 FLX.021 FLX.022 FLX.023 FLX.025 FLX.027 FLX.026 FLX.029 FLX.032 FLX.028 FLX.033 FLX.034 FLX.030 FLX.031 FLX.036 FLX.035 FLX.041 FLX.040 FLX.038 FLX.037 FLX.045 FLX.044 FLX.046 FLX.043 FLX.047 FLX.057 FLX.039 FLX.048 FLX.051 FLX.055 FLX.053 FLX.052 FLX.054 FLX.060 FLX.059 FLX.063 FLX.058 FLX.049 FLX.056 FLX.050 FLX.042 FLX.062 FLX.061 FLX.064 FLX.067 FLX.068 FLX.065 FLX.069 FLX.066 FLX.072 FLX.070 FLX.071 FLX.073 FLX.075 FLX.078 FLX.079 FLX.074 FLX.081 FLX.076 FLX.077 FLX.080 FLX.082 FLX.084 FLX.088 FLX.083 FLX.086 FLX.089 FLX.087 FLX.092 FLX.091 FLX.085 FLX.090 FLX.093 FLX.095 FLX.096 FLX.094 FLX.099 FLX.097 FLX.101 FLX.048 FLX.103 FLX.102 FLX.098 FLX.0104 FLX.0105 FLX.0106 FLX.0108 FLX.0107 FLX.0109 FLX.0112 FLX.0113 FLX.0111 FLX.0114 FLX.0115 FLX.100 FLX.0110 FLX.0116 FLX.0117 FLX.0119 FLX.0120 FLX.0118 FLX.0121 FLX.0123 FLX.0122 FLX.0124 FLX.0125 FLX.0130 FLX.0127 FLX.0128 FLX.0129 FLX.0131 FLX.0132 FLX.0134 FLX.0126 FLX.0133 FLX.0136 FLX.0139 FLX.0135 FLX.0138 FLX.0137 FLX.0141 FLX.0142 FLX.0140 FLX.0144 FLX.0143 FLX.0145 FLX.0146 FLX.0147 FLX.0148 FLX.0149 FLX.0150 FLX.0151 FLX.0153 FLX.0154 FLX.0156 FLX.0159 FLX.0155 FLX.0152 FLX.0158 FLX.0157 FLX.0161 FLX.0162 FLX.0160 FLX.0163 FLX.0164 FLX.0165 FLX.0166 FLX.0167 FLX.0168 FLX.0169 FLX.0170 FLX.0171 FLX.0172 FLX.0174 FLX.0173 FLX.0175 FLX.0176 FLX.0177 FLX.0179 FLX.0178 FLX.0180 FLX.0182 FLX.0181 FLX.0183 FLX.0184 FLX.0185 FLX.0186 FLX.0187 FLX.0188 FLX.0189 FLX.0193 FLX.0191 FLX.0192 FLX.0194 FLX.0196 Accelerator a3600: ACP.001 ACP.002 ACP.003 ACP.004 ACP.005 ACP.006 ACP.008 ACP.007 ACP.010 ACP.009 ACP.011 ACP.012 ACP.014 ACP.013 ACP.017 ACP.016 ACP.015 ACP.020 ACP.021 ACP.019 ACP.022 ACP.023 ACP.024 ACP.025 ACP.027 ACP.026 ACP.028 ACP.029 ACP.030 ACP.031 ACP.033 ACP.032 ACP.035 ACP.036 ACP.037 ACP.038 ACP.039 ACP.040…
FDA’s list runs to 5,764 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.
Foreign distribution to Netherlands, Italy, Belgium, Austria, France, Spain, and Germany.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Aug 24, 2018.
- FDA classified it on Oct 31, 2018.
- FDA’s Enforcement Report published it on Nov 7, 2018.
- FDA terminated it on Mar 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Inpeco S.A., of Lugano, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 5,764 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
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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.