Reported Oct 20, 2021 · Ongoing

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

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?

  • FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Lot codes and dates
  • Impacted Module
    • ADVIA Centaur XP/XPT Interface Module
    • Part No. FLX-021-00
    • FLX-021-10
  • APT-021-00 Serial numbers***FLEXLAB***
    • FLX.0109
    • FLX.0127
    • FLX.0128
    • FLX.0129
    • FLX.0132
    • FLX.0133
    • FLX.0139
    • FLX.0146
    • FLX.0147
    • FLX.0149
    • FLX.0151
    • FLX.0153
    • FLX.0154
    • FLX.0156
    • FLX.0157
    • FLX.0159
    • FLX.0160
    • FLX.0162
    • FLX.0165
    • FLX.0166
    • FLX.0167
    • FLX.0169
    • FLX.0170
    • FLX.0172
    • FLX.0173
    • FLX.0174
    • FLX.0179
    • FLX.0180
    • FLX.0182
    • FLX.0191
    • FLX.0192
    • FLX.0193
    • FLX.0194
    • FLX.043
    • FLX.069
    • FLX.085
    • FLX.086
    • FLX.087
    • FLX.093
    • FLX.097
    ***ACCELERATOR a3600*** ACP.334 ***APTIO AUTOMATION***

    221 of 221 codes

    • AP2.0002
    • AP2.0003
    • AP2.0004
    • AP2.0005
    • AP2.0006
    • AP2.0007
    • AP2.0008
    • AP2.009
    • AP2.0010
    • AP2.0011
    • AP2.0012
    • AP2.0014
    • AP2.0015
    • AP2.0016
    • AP2.0017
    • AP2.0018
    • AP2.0019
    • AP2.0022
    • AP2.0023
    • AP2.0024
    • AP2.0025
    • AP2.0026
    • AP2.0027
    • AP2.0028
    • AP2.0029
    • AP2.0031
    • AP2.0032
    • AP2.0033
    • AP2.0035
    • AP2.0037
    • AP2.0038
    • AP2.0039
    • AP2.0040
    • AP2.0041
    • AP2.0043
    • AP2.0045
    • AP2.0046
    • AP2.0047
    • AP2.0048
    • AP2.0049
    • AP2.0050
    • AP2.0051
    • AP2.0052
    • AP2.0053
    • AP2.0054
    • AP2.0055
    • AP2.0057
    • AP2.0058
    • AP2.0059
    • AP2.0061
    • AP2.0062
    • AP2.0063
    • AP2.0064
    • AP2.0065
    • AP2.0066
    • AP2.0067
    • AP2.0070
    • AP2.0075
    • AP2.0076
    • AP2.0077
Amount recalled
262 total, 52 US

Where it was sold

  • Nationwide

Why it was recalled

The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 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.