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U.S. Department of Health and Human Services

Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)

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  Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) see related information
Date Initiated by Firm August 24, 2018
Create Date October 31, 2018
Recall Status1 Terminated 3 on March 19, 2020
Recall Number Z-0361-2019
Recall Event ID 81124
510(K)Number K121012  
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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,
Code Information 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 ACP.042 ACP.034 ACP.043 ACP.044 ACP.041 ACP.046 ACP.047 ACP.048 ACP.045 ACP.049 ACP.050 ACP.051 ACP.053 ACP.054 ACP.055 ACP.052 ACP.056 ACP.057 ACP.059 ACP.058 ACP.061 ACP.060 ACP.063 ACP.018 ACP.064 ACP.065 ACP.066 ACP.067 ACP.068 ACP.069 ACP.073 ACP.070 ACP.071 ACP.072 ACP.062 ACP.075 ACP.074 ACP.076 ACP.077 ACP.078 ACP.079 ACP.080 ACP.081 ACP.082 ACP.084 ACP.085 ACP.087 ACP.086 ACP.093 ACP.089 ACP.090 ACP.088 ACP.091 ACP.092 ACP.094 ACP.095 ACP.083 ACP.096 ACP.097 ACP.098 ACP.099 ACP.100 ACP.104 ACP.102 ACP.105 ACP.101 ACP.103 ACP.108 ACP.106 ACP.109 ACP.110 ACP.111 ACP.112 ACP.107 ACP.113 ACP.114 ACP.115 ACP.117 ACP.116 ACP.119 ACP.118 ACP.120 ACP.121 ACP.122 ACP.125 ACP.124 ACP.123 ACP.126 ACP.128 ACP.127 ACP.129 ACP.131 ACP.135 ACP.134 ACP.132 ACP.133 ACP.130 ACP.136 ACP.137 ACP.139 ACP.138 ACP.140 ACP.142 ACP.143 ACP.144 ACP.145 ACP.141 ACP.146 ACP.147 ACP.148 ACP.149 ACP.150 ACP.151 ACP.152 ACP.153 ACP.154 ACP.155 ACP.156 ACP.157 ACP.158 ACP.159 ACP.160 ACP.161 ACP.162 ACP.163 ACP.164 ACP.165 ACP.170 ACP.169 ACP.166 ACP.167 ACP.168 ACP.171 ACP.173 ACP.174 ACP.175 ACP.172 ACP.176 ACP.177 ACP.178 ACP.182 ACP.179 ACP.180 ACP.183 ACP.184 ACP.181 ACP.187 ACP.185 ACP.186 ACP.188 ACP.189 ACP.191 ACP.190 ACP.194 ACP.193 ACP.195 ACP.192 ACP.196 ACP.197 ACP.198 ACP.199 ACP.201 ACP.200 ACP.202 ACP.203 ACP.206 ACP.207 ACP.204 ACP.209 ACP.205 ACP.214 ACP.208 ACP.218 ACP.217 ACP.210 ACP.211 ACP.215 ACP.212 ACP.213 ACP.216 ACP.219 ACP.222 ACP.220 ACP.221 ACP.225 ACP.223 ACP.224 ACP.226 ACP.227 ACP.228 ACP.229 ACP.230 ACP.231 ACP.233 ACP.232 ACP.234 ACP.235 ACP.237 ACP.236 ACP.238 ACP.239 ACP.240 ACP.241 ACP.242 ACP.244 ACP.245 ACP.246 ACP.243 ACP.249 ACP.247 ACP.248 ACP.251 ACP.252 ACP.253 ACP.254 ACP.257 ACP.255 ACP.258 ACP.259 ACP.256 ACP.260 ACP.262 ACP.265 ACP.264 ACP.261 ACP.266 ACP.250 ACP.268 ACP.267 ACP.269 ACP.271 ACP.272 ACP.275 ACP.274 ACP.276 ACP.277 ACP.278 ACP.280 ACP.270 ACP.281 ACP.279 ACP.285 ACP.282 ACP.283 ACP.284 ACP.273 ACP.273 ACP.286  Aptio Automation: APT.0009 APT.0091 APT.0136 AP2.0001 AP2.0002 AP2.0005 AP2.0003 AP2.0004 AP2.0007 AP2.0006 APT.0275 AP2.0008 AP2.0011 AP2.0010 AP2.0012 AP2.0009 AP2.0013 AP2.0014 AP2.0015 AP2.0016 AP2.0021 AP2.0017 AP2.0018 AP2.0019 AP2.0020 AP2.0023 AP2.0024 AP2.0027 AP2.0025 AP2.0030 AP2.0022 AP2.0026 AP2.0028 AP2.0029 AP2.0031 AP2.0033 AP2.0034 AP2.0035 AP2.0032 AP2.0036 AP2.0037 AP2.0038 AP2.0039 AP2.0040 AP2.0041 AP2.0043 AP2.0045 AP2.0044 AP2.0046 AP2.0047 AP2.0048 AP2.0049 AP2.0052 AP2.0050 AP2.0053 AP2.0054 AP2.0042 AP2.0069 AP2.0077 AP2.0056 AP2.0055 AP2.0051 AP2.0058 AP2.0057 AP2.0060 AP2.0059 AP2.0063 AP2.0065 AP2.0062 AP2.0064 AP2.0061 AP2.0066 AP2.0068 AP2.0073 AP2.0071 AP2.0074 AP2.0070 AP2.0067 AP2.0075 AP2.0072 AP2.0078 AP2.0079 AP2.0081 AP2.0082 AP2.0076 AP2.0083 AP2.0080 AP2.0085 AP2.0092 AP2.0090 AP2.0094 AP2.0095 AP2.0088 AP2.0089 AP2.0084 AP2.0093 AP2.0096 AP2.0087 AP2.0098 AP2.0097 AP2.0099 AP2.0100 AP2.0101 AP2.0086 AP2.0091 AP2.0102 AP2.0103 AP2.0105 AP2.0104 AP2.0106 AP2.0107 AP2.0109 AP2.0108 AP2.0112 AP2.0114 AP2.0111 AP2.0110 AP2.0113 AP2.0118 AP2.0117 AP2.0119 AP2.0120 AP2.0122 AP2.0123 AP2.0124 AP2.0125 AP2.0121 AP2.0126 AP2.0127 AP2.0139 AP2.0129 AP2.0128 AP2.0130 AP2.0131 AP2.0134 AP2.0135 AP2.0136 AP2.0116 AP2.0133 AP2.0140 AP2.0141 AP2.0142 AP2.0138 AP2.0144 AP2.0143 AP2.0145 AP2.0150 AP2.0152 AP2.0132 AP2.0146 AP2.0151 AP2.0148 AP2.0137 AP2.0149 AP2.0153 AP2.0156 AP2.0157 AP2.0158 AP2.0159 AP2.0160 AP2.0147 AP2.0161 AP2.0162 AP2.0163 AP2.0154 AP2.0164 AP2.0166 AP2.0165 AP2.0167 AP2.0168 AP2.0170 AP2.0171 AP2.0172 AP2.0173 AP2.0174 AP2.0175 AP2.0177 AP2.0169 AP2.0182 AP2.0155 AP2.0180 AP2.0178 AP2.0181 AP2.0179 AP2.0184 AP2.0183 AP2.0185 AP2.0186 AP2.0187 AP2.0188 AP2.0190 AP2.0193 AP2.0191 AP2.0192 AP2.0194 AP2.0195  
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Under Investigation by firm
Action On 8/24/18, the firm, Inpeco, notified distributors of the recall via an "Urgent IVD Medical Device Recall" letter dated August 2018. Distributors were informed of the product issue and instructed to further notify end users. Advise on action to be taken by the user: 1. Please be aware that personnel fitted with a pacemaker must not handle or work on these modules at distances lower than 200 mm even if the warning label is missing. 2. Please review the attached OM Errata Sheet and save it with the Operations Manual you currently have available for future references regarding the "safety distance" required for pacemakers. 3. Please verify that the modules listed in Table 1 have the pacemaker safety label attached. If the safety pacemaker label is missing, please remove the last page of this letter and tape the copy of the label on the cover of these modules until the official label is available. If your site is included in the list of Systems where at least one pacemaker label is missing, lnpeco Service or their representatives will contact you to arrange a visit to address the described problem and apply the missing labels. In addition: " complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to lnpeco or to lnpeco representative. If you have any questions or concerns regarding this recall, please contact Giorgia Amabile, Quality and Regulatory Manager, at Regulatory.Affairs@inpeco.com, or (+41) 91-9118-258.
Quantity in Commerce 679
Distribution Foreign distribution to Netherlands, Italy, Belgium, Austria, France, Spain, 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.
510(K) Database 510(K)s with Product Code = JQP and Original Applicant = INPECO S.P.A.
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