FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple…
Medical device recall Z-2198-2020. 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
- 71 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?
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 the hydraulic circuit of the Aliquoter Module.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
71 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 612 characters
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
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.