| Date Initiated by Firm |
April 07, 2020 |
| Create Date |
June 01, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2200-2020 |
| Recall Event ID |
85469 |
| 510(K)Number |
K121012
|
| Product Classification |
Electrode, ion specific, potassium - Product Code CEM
|
| Product |
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation. |
| Code Information |
Serial Numbers: AP2.0005 AP2.0008 AP2.0010 AP2.0014 AP2.0017 AP2.0018 AP2.0022 AP2.0023 AP2.0026 AP2.0027 AP2.0033 AP2.0036 AP2.0039 AP2.0043 AP2.0045 AP2.0056 AP2.0060 AP2.0065 AP2.0069 AP2.0070 AP2.0071 AP2.0076 AP2.0078 AP2.0081 AP2.0087 AP2.0089 AP2.0102 AP2.0104 AP2.0105 AP2.0110 AP2.0111 AP2.0113 AP2.0120 AP2.0127 AP2.0137 AP2.0139 AP2.0146 AP2.0147 AP2.0149 AP2.0151 AP2.0155 AP2.0165 AP2.0170 AP2.0172 AP2.0184 AP2.0189 AP2.0201 AP2.0202 AP2.0203 AP2.0209 AP2.0211 AP2.0213 AP2.0217 AP2.0223 APT.0009 APT.0014 APT.0058 APT.0065 APT.0093 APT.0091 APT.0125 |
Recalling Firm/
Manufacturer |
Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
|
Manufacturer Reason
for Recall |
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 Determined
Cause 2 |
Software design |
| 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 |
| Quantity in Commerce |
61 systems |
| Distribution |
US Nationwide distribution including in the states of IL, NY. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
| 510(K) Database |
510(K)s with Product Code = CEM and Original Applicant = INPECO S.P.A.
|
