| Date Initiated by Firm |
April 07, 2020 |
| Create Date |
June 01, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2199-2020 |
| Recall Event ID |
85469 |
| 510(K)Number |
K121012
|
| Product Classification |
Electrode, ion specific, potassium - Product Code CEM
|
| Product |
Accelerator a3600 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: 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 ACP.232 ACP.233 ACP.235 ACP.236 ACP.237 ACP.242 ACP.243 ACP.244 ACP.248 ACP.250 ACP.252 ACP.253 ACP.257 ACP.258 ACP.259 ACP.263 ACP.265 ACP.267 ACP.268 ACP.275 ACP.276 ACP.280 ACP.286 ACP.289 ACP.290 ACP.291 ACP.294 ACP.295 ACP.297 ACP.298 ACP.299 ACP.303 ACP.304 ACP.314 ACP.323 ACP.332 ACP.336 |
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 |
97 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.
|
