Inpeco S.A.: Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of

Agency Publication Date: June 1, 2020

Affected Products

Product: FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.

Serial Numbers: FLX.008 FLX.0105 FLX.0106 FLX.0107 FLX.0113 FLX.0114 FLX.0115 FLX.0116 FLX.0118 FLX.0119 FLX.012 FLX.0121 FLX.0124 FLX.0125 FLX.0126 FLX.0127 FLX.0128 FLX.0129 FLX.0131 FLX.0135 FLX.0136 FLX.0138 FLX.014 FLX.0140 FLX.0141 FLX.0143 FLX.015 FLX.0152 FLX.0155 FLX.0158 FLX.0161 FLX.0164 FLX.017 FLX.018 FLX.0196 FLX.020 FLX.021 FLX.022 FLX.023 FLX.027 FLX.029 FLX.030 FLX.031 FLX.032 FLX.033 FLX.037 FLX.038 FLX.039 FLX.043 FLX.044 FLX.046 FLX.047 FLX.050 FLX.051 FLX.052 FLX.056 FLX.060 FLX.064 FLX.071 FLX.072 FLX.074 FLX.075 FLX.076 FLX.077 FLX.080 FLX.082 FLX.083 FLX.093 FLX.101 FLX.102 TSH.003

Product: Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

Serial Numbers: ACP.002 ACP.004 ACP.009 ACP.011 ACP.012 ACP.015 ACP.018 ACP.019 ACP.026 ACP.027 ACP.028 ACP.033 ACP.034 ACP.042 ACP.045 ACP.047 ACP.048 ACP.050 ACP.052 ACP.059 ACP.061 ACP.063 ACP.064 ACP.066 ACP.069 ACP.070 ACP.071 ACP.073 ACP.076 ACP.085 ACP.088 ACP.092 ACP.093 ACP.101 ACP.102 ACP.104 ACP.113 ACP.119 ACP.120 ACP.123 ACP.131 ACP.141 ACP.142 ACP.146 ACP.163 ACP.164 ACP.171 ACP.172 ACP.182 ACP.185 ACP.186 ACP.194 ACP.205 ACP.209 ACP.214 ACP.217 ACP.218 ACP.226 ACP.229 ACP.230 ACP.232 ACP.233 ACP.235 ACP.236 ACP.237 ACP.242 ACP.243 ACP.244 ACP.248 ACP.250 ACP.252 ACP.253 ACP.257 ACP.258 ACP.259 ACP.263 ACP.265 ACP.267 ACP.268 ACP.275 ACP.276 ACP.280 ACP.286 ACP.289 ACP.290 ACP.291 ACP.294 ACP.295 ACP.297 ACP.298 ACP.299 ACP.303 ACP.304 ACP.314 ACP.323 ACP.332 ACP.336

Product: Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

Serial Numbers: AP2.0005 AP2.0008 AP2.0010 AP2.0014 AP2.0017 AP2.0018 AP2.0022 AP2.0023 AP2.0026 AP2.0027 AP2.0033 AP2.0036 AP2.0039 AP2.0043 AP2.0045 AP2.0056 AP2.0060 AP2.0065 AP2.0069 AP2.0070 AP2.0071 AP2.0076 AP2.0078 AP2.0081 AP2.0087 AP2.0089 AP2.0102 AP2.0104 AP2.0105 AP2.0110 AP2.0111 AP2.0113 AP2.0120 AP2.0127 AP2.0137 AP2.0139 AP2.0146 AP2.0147 AP2.0149 AP2.0151 AP2.0155 AP2.0165 AP2.0170 AP2.0172 AP2.0184 AP2.0189 AP2.0201 AP2.0202 AP2.0203 AP2.0209 AP2.0211 AP2.0213 AP2.0217 AP2.0223 APT.0009 APT.0014 APT.0058 APT.0065 APT.0093 APT.0091 APT.0125

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85469

Status: Active

Manufacturer: Inpeco S.A.

Manufactured In: Switzerland

Units Affected: 3 products (71 systems; 97 systems; 61 systems)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.

Product: Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

Product: Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.