# FDA recall Z-1561-2023

> **Inpeco S.A.** · Class II · device recall initiated 2023-03-10.

## Product

PVT Interface Module (PVT)-Laboratory Automation system    Brand names of the same product: FlexLab (FLX), Accelerator  a3600 (ACP), Aptio Automation (AP2)    Part Numbers: 72747000.A

## Reason for recall

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 

## 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.

## Key facts

- **Recall number:** Z-1561-2023
- **Recalling firm:** Inpeco S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lugano, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2023

## Citation

> AI Analytics. FDA recall Z-1561-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1561-2023. Source: US FDA. Licensed CC0.

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