Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The…
Medical device recall Z-2199-2020. Published in FDA’s Enforcement Report on Jun 10, 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 Jun 10, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 97 systems 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?
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 the hydraulic circuit of the Aliquoter Module.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
97 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 791 characters
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
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.
US Nationwide distribution including in the states of IL, NY.
The states and territories these words name
- Illinois
- New York
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Apr 7, 2020.
- FDA classified it on Jun 1, 2020.
- FDA’s Enforcement Report published it on Jun 10, 2020.
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.