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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Inpeco S.A.
- Reason for Recall:
- 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 that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0433-2021
Related Recalls
FlexLab (FLX); Version: FLX-217-40;
Inpeco S.A.
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
FlexLab (FLX); Version: FLX-217-10;
Inpeco S.A.
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.