Reported Nov 7, 2018 · Terminated
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio…
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) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
- Lot codes and dates
- FlexLabSHL.001 TSH.003 FLX.003 DIA 007 DIA
193 of 193 codes
008AML.001SHD.001SHD.002SHD.003FLX.006FLX.005FLX.008FLX.011FLX.009FLX.010FLX.012FLX.014FLX.015FLX.017FLX.018FLX.016FLX.019FLX.020FLX.021FLX.022FLX.023FLX.025FLX.027FLX.026FLX.029FLX.032FLX.028FLX.033FLX.034FLX.030FLX.031FLX.036FLX.035FLX.041FLX.040FLX.038FLX.037FLX.045FLX.044FLX.046FLX.043FLX.047FLX.057FLX.039FLX.048FLX.051FLX.055FLX.053FLX.052FLX.054FLX.060FLX.059FLX.063FLX.058FLX.049FLX.056FLX.050FLX.042FLX.062
- Accelerator a3600
286 of 286 codes
ACP.001ACP.002ACP.003ACP.004ACP.005ACP.006ACP.008ACP.007ACP.010ACP.009ACP.011ACP.012ACP.014ACP.013ACP.017ACP.016ACP.015ACP.020ACP.021ACP.019ACP.022ACP.023ACP.024ACP.025ACP.027ACP.026ACP.028ACP.029ACP.030ACP.031ACP.033ACP.032ACP.035ACP.036ACP.037ACP.038ACP.039ACP.040ACP.042ACP.034ACP.043ACP.044ACP.041ACP.046ACP.047ACP.048ACP.045ACP.049ACP.050ACP.051ACP.053ACP.054ACP.055ACP.052ACP.056ACP.057ACP.059ACP.058ACP.061ACP.060
- Aptio Automation
196 of 196 codes
APT.0009APT.0091APT.0136AP2.0001AP2.0002AP2.0005AP2.0003AP2.0004AP2.0007AP2.0006APT.0275AP2.0008AP2.0011AP2.0010AP2.0012AP2.0009AP2.0013AP2.0014AP2.0015AP2.0016AP2.0021AP2.0017AP2.0018AP2.0019AP2.0020AP2.0023AP2.0024AP2.0027AP2.0025AP2.0030AP2.0022AP2.0026AP2.0028AP2.0029AP2.0031AP2.0033AP2.0034AP2.0035AP2.0032AP2.0036AP2.0037AP2.0038AP2.0039AP2.0040AP2.0041AP2.0043AP2.0045AP2.0044AP2.0046AP2.0047AP2.0048AP2.0049AP2.0052AP2.0050AP2.0053AP2.0054AP2.0042AP2.0069AP2.0077AP2.0056
- FlexLabSHL.001 TSH.003 FLX.003 DIA 007 DIA
- Amount recalled
- 679
Why it was recalled
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.
This product could cause temporary or reversible health problems — stop using it.
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