Reported Jun 10, 2020 · Ongoing

Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems…

Inpeco S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano, N/A · N/A

Is this the product you have?

  • Accelerator a3600 Automation System using the Aliquoter Module (Inpeco
  • P/N FLX-212) - Product UsageThe systems consolidate multiple Analytical instruments into a unified workstation
Lot codes and dates
  • Serial Numbers

    97 of 97 codes

    • 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
Amount recalled
97 systems

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Inpeco S.A. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.