Inpeco FlexLab Automation System Recalled for Potential Sample Dilution
Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (erroneous test results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Inpeco S.A. is recalling 93 FlexLab (FLX) Automation Systems equipped with the Aliquoter Module (Inpeco P/N FLX-212). The recall affects specific firmware versions and system serial numbers distributed globally, including in the United States and numerous international markets.
The recall is due to a software defect in the clot detection process. When a clot detection error occurs during sample aspiration, the system may dispense the aspirated volume into a secondary sample tube that has been diluted with water from the hydraulic circuit. The associated error messages do not clearly warn operators that the sample may be diluted, which can lead to the reporting of erroneous laboratory results if the affected sample is used for testing.
Healthcare facilities and laboratories that have installed the affected FlexLab systems should contact Inpeco S.A. for instructions on how to manage the recall and ensure accurate sample processing.
The recalled product
- Product
- FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processin
- Manufacturer
- Inpeco S.A.
- Affected units
- 93
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Inpeco S.A.
See all →- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighFlexLab X system recalled over unevaluated blood sample integrity function
FDA (Devices) · 2025-10-15
- HighLaboratory automation systems recalled over unevaluated sample integrity function
FDA (Devices) · 2025-10-15
- ModerateRoche Cobas Interface Module Firmware May Cause Delayed Sample Processing
FDA (Devices) · 2023-12-27
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
- HighBlood tubes recalled after being manufactured without the gel separator
FDA (Devices) · 2025-11-26
- HighAllergy IgE universal kits recalled over barcodes misordering tubes in wedges
FDA (Devices) · 2025-11-19