Inpeco S.A.: When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify th

Agency Publication Date: November 6, 2020

Affected Products

Product: FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System Serial Numbers: FLX.008 FLX.0118 FLX.064 FLX.101 FLX.0116 FLX.0125 FLX.080 FLX.0206 FLX.0161 FLX.0152 FLX.012 FLX.0121 FLX.0155 FLX.033 FLX.047 FLX.0127 FLX.0128 FLX.0129 FLX.074 FLX.076 FLX.0113 FLX.0138 FLX.014 FLX.015 FLX.0164 FLX.051 FLX.0106 FLX.0158 FLX.0196 FLX.072 FLX.0107 FLX.0189 FLX.0126 FLX.0165 FLX.0135 FLX.017 FLX.0114 FLX.022 FLX.0119 FLX.0105 FLX.029 FLX.0115 FLX.031 FLX.032 FLX.0141 FLX.037 FLX.020 FLX.039 FLX.043 FLX.102 FLX.046 FLX.0143 FLX.050 FLX.0124 FLX.0131 FLX.056 FLX.060 FLX.0136 FLX.0140 FLX.018 FLX.021 FLX.023 FLX.030 FLX.044 FLX.052 FLX.082 FLX.083 FLX.093 FLX.071 FLX.077 TSH.003 FLX.0146 FLX.027 FLX.038 FLX.075 FLX.0160 FLX.0153 FLX.0154 FLX.0157 FLX.0166 FLX.0167 FLX.0170 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0194 FLX.0183 FLX.0048 FLX.0049 FLX.0109 FLX.0145 FLX.0148

Product: Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System Serial Numbers: ACP.048 ACP.142 ACP.194 ACP.113 ACP.104 ACP.244 ACP.252 ACP.253 ACP.268 ACP.290 ACP.363 ACP.181 ACP.009 ACP.015 ACP.027 ACP.042 ACP.092 ACP.432 ACP.303 ACP.004 ACP.011 ACP.028 ACP.093 ACP.163 ACP.226 ACP.275 ACP.267 ACP.276 ACP.329 ACP.033 ACP.012 ACP.235 ACP.064 ACP.164 ACP.209 ACP.217 ACP.263 ACP.295 ACP.297 ACP.323 ACP.396 ACP.410 ACP.115 ACP.214 ACP.331 ACP.243 ACP.259 ACP.085 ACP.141 ACP.237 ACP.172 ACP.218 ACP.257 ACP.280 ACP.336 ACP.364 ACP.298 ACP.337 ACP.066 ACP.088 ACP.123 ACP.248 ACP.182 ACP.442 ACP.291 ACP.026 ACP.047 ACP.171 ACP.265 ACP.426 ACP.018 ACP.286 ACP.102 ACP.063 ACP.076 ACP.230 ACP.233 ACP.258 ACP.334 ACP.360 ACP.378 ACP.391 ACP.437 ACP.250 ACP.314 ACP.439 ACP.440 ACP.073 ACP.185 ACP.186 ACP.146 ACP.205 ACP.371 ACP.394 ACP.270 ACP.272 ACP.284 ACP.318 ACP.002 ACP.019 ACP.034 ACP.045 ACP.050 ACP.052 ACP.059 ACP.061 ACP.069 ACP.070 ACP.071 ACP.101 ACP.119 ACP.120 ACP.131 ACP.229 ACP.232 ACP.236 ACP.242 ACP.289 ACP.294 ACP.299 ACP.304 ACP.332 ACP.321 ACP.342 ACP.344 ACP.359 ACP.361 ACP.372 ACP.375 ACP.424 ACP.428 ACP.431 ACP.436 ACP.451 ACP.454 ACP.278

Product: Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System 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 AP2.0225 AP2.0230 AP2.0232 AP2.0233 AP2.0240 AP2.0242 AP2.0253 AP2.0266 AP2.0265 AP2.0268 AP2.0269 AP2.0238 AP2.0248 AP2.0274 AP2.0283 AP2.0289 AP2.0285 AP2.0295 AP2.0296 AP2.0303 AP2.0308 AP2.0332 AP2.0350 AP2.0353 AP2.0352 AP2.0354 AP2.0346 AP2.0361 AP2.0366 AP2.0388 AP2.0393 AP2.0402 AP2.0403 AP2.0404 AP2.0405 AP2.0389 AP2.0390 AP2.0400 AP2.0401 AP2.0421 AP2.0420 AP2.0427 AP2.0412

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86581

Status: Resolved

Manufacturer: Inpeco S.A.

Manufactured In: Switzerland

Units Affected: 3 products (93; 136; 104)

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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

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Affected Products

The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System Serial Numbers: ACP.048 ACP.142 ACP.194 ACP.113 ACP.104 ACP.244 ACP.252 ACP.253 ACP.268 ACP.290 ACP.363 ACP.181 ACP.009 ACP.015 ACP.027 ACP.042 ACP.092 ACP.432 ACP.303 ACP.004 ACP.011 ACP.028 ACP.093 ACP.163 ACP.226 ACP.275 ACP.267 ACP.276 ACP.329 ACP.033 ACP.012 ACP.235 ACP.064 ACP.164 ACP.209 ACP.217 ACP.263 ACP.295 ACP.297 ACP.323 ACP.396 ACP.410 ACP.115 ACP.214 ACP.331 ACP.243 ACP.259 ACP.085 ACP.141 ACP.237 ACP.172 ACP.218 ACP.257 ACP.280 ACP.336 ACP.364 ACP.298 ACP.337 ACP.066 ACP.088 ACP.123 ACP.248 ACP.182 ACP.442 ACP.291 ACP.026 ACP.047 ACP.171 ACP.265 ACP.426 ACP.018 ACP.286 ACP.102 ACP.063 ACP.076 ACP.230 ACP.233 ACP.258 ACP.334 ACP.360 ACP.378 ACP.391 ACP.437 ACP.250 ACP.314 ACP.439 ACP.440 ACP.073 ACP.185 ACP.186 ACP.146 ACP.205 ACP.371 ACP.394 ACP.270 ACP.272 ACP.284 ACP.318 ACP.002 ACP.019 ACP.034 ACP.045 ACP.050 ACP.052 ACP.059 ACP.061 ACP.069 ACP.070 ACP.071 ACP.101 ACP.119 ACP.120 ACP.131 ACP.229 ACP.232 ACP.236 ACP.242 ACP.289 ACP.294 ACP.299 ACP.304 ACP.332 ACP.321 ACP.342 ACP.344 ACP.359 ACP.361 ACP.372 ACP.375 ACP.424 ACP.428 ACP.431 ACP.436 ACP.451 ACP.454 ACP.278

The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System 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 AP2.0225 AP2.0230 AP2.0232 AP2.0233 AP2.0240 AP2.0242 AP2.0253 AP2.0266 AP2.0265 AP2.0268 AP2.0269 AP2.0238 AP2.0248 AP2.0274 AP2.0283 AP2.0289 AP2.0285 AP2.0295 AP2.0296 AP2.0303 AP2.0308 AP2.0332 AP2.0350 AP2.0353 AP2.0352 AP2.0354 AP2.0346 AP2.0361 AP2.0366 AP2.0388 AP2.0393 AP2.0402 AP2.0403 AP2.0404 AP2.0405 AP2.0389 AP2.0390 AP2.0400 AP2.0401 AP2.0421 AP2.0420 AP2.0427 AP2.0412