| Date Initiated by Firm | April 07, 2020 |
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| Create Date | June 01, 2020 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2198-2020 |
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| Recall Event ID |
85469 |
| 510(K)Number | K121012 |
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| Product Classification |
Electrode, ion specific, potassium - Product Code CEM
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| Product | FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation. |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software design |
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| Action | Urgent: Medical Device Correction dated 03/30/2020 were sent to customers.
The impacted modules are the Aliquoter Modules (Inpeco Part Number FLX-212) with a firmware version prior to the following:
AQMb_3-3-0.H86; AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86; xAQMb_1-1-0.elf;
Action to be taken by the user
To avoid the risk of contamination take the following precaution:
1) Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory
guidelines considering that it may be diluted.
2) Call Service Assistant in case the frequency of the Clot Detection Error increases (more than 5 consecutive Clot Detection Errors).
Your service provider will contact you to schedule the firmware upgrade.
Until the service visit please maintain awareness on this notice.
Please complete and return the "Customer Letter Receipt Confirmation and Implementation CHeck form" attached to this letter with 15 days directly at the email address specified in the email communication.
Contact reference person:
FOr any clarificatino you may need, do not hesitate to ocntact:
Eva Balzarotti - REgulatory Affairs Manager
E-mail: regulatory.affairs@inpeco.com
Phone: (+41) 91 9118 224 |
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| Quantity in Commerce | 71 systems |
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| Distribution | US Nationwide distribution including in the states of IL, NY. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = CEM
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