Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka…
Medical device recall Z-0433-2021. Published in FDA’s Enforcement Report on Nov 18, 2020.
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 18, 2020. 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
- 136 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
136, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,313 characters
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
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.
Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
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 Jul 14, 2020.
- FDA classified it on Nov 6, 2020.
- FDA’s Enforcement Report published it on Nov 18, 2020.
- FDA terminated it on Dec 28, 2023.
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.”
- 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.