Recall record at a glance
| Official record | Z-1559-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Inpeco S.A. |
| Report date | May 10, 2023 |
| Recall initiation date | Mar 10, 2023 |
| Quantity | US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems). |
| Location | Lugano, Switzerland |
Official product description
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
Why the product was recalled
Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.
Distribution information
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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