Agency classClass IIOur severity:High FDA (Devices)·Z-0587-2017·Announced 2016-11-23

Inpeco Laboratory Automation Systems Recalled for Burnt Sockets

Inpeco is recalling FlexLab, Accelerator a3600, and Aptio Automation systems because field reports indicate burnt Schuko sockets and smoke.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a risk-of-harm product (electrical fire/smoke) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Inpeco S.A. is recalling 188 units of FlexLab, Accelerator a3600, and Aptio Automation modular laboratory systems. These systems are designed to automate pre-analytical and post-analytical processing and sample handling in laboratory settings.

The recall was initiated after Inpeco received several notifications from the field regarding burnt Schuko sockets. Customers reported seeing smoke coming from the damaged sockets. The affected components include specific Schuko sockets with part numbers 693822160, 693822170, 693822190, and 0C00005640, associated with the CMSA/HETTICH - STORAGE - i2000SR model.

The affected units were distributed worldwide, including in the United States (specifically Texas and New York) and foreign consignees in Germany, Italy, France, Austria, and Spain. Users should identify their equipment by checking the serial numbers listed in the official recall documentation.

The recalled product

Product: FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a…
Manufacturer: Inpeco S.A.
Category: Medical Device — Laboratory Automation
Hazard: fire
burn-injury
Affected units: 188

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Shucko Socket with P/N: 693822160
Model: CMSA/HETTICH - STORAGE - i2000SR
Length: 3 meters
Shucko Socket with P/N: 693822170
Length: 5 meters
Shucko Socket with P/N: 693822190
Length: 7 meters
Shucko Socket with P/N: 0C00005640
ACP.024
ACP.039
ACP.054
ACP.069
ACP.084
ACP.100
ACP.115
ACP.010
ACP.025
ACP.040
ACP.055
ACP.070

Distribution

Distributed in 2 states:

Same manufacturer · Inpeco S.A.

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