Is 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 recalled?

Question

Is 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 recalled?

Accepted Answer

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.

Status: Voluntary: Firm initiated

Initial Firm Notification: Letter

Distribution: 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.

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