Inpeco FlexLab and Accelerator a3600 Recalled for Missing Safety Labels
Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.
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 pacemaker malfunction, which is a serious potential injury, but no injuries or illnesses have been reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Inpeco S.A. is recalling 679 units of the FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2) modular systems. These systems are designed to automate pre-analytical and post-analytical processing in laboratory settings. The recall was initiated because the firm identified customer sites where specific modules were missing the required safety pacemaker label.
The missing label contained critical safety information regarding the risk of pacemaker malfunction for individuals working on these modules. The Operations Manual has been updated to specify that the minimum safety distance from the transport mechanisms has been increased to 200 mm (7.87 inches). The updated guidance states that any person with a pacemaker must not get closer than this distance from the modules' axes.
The affected units were distributed to the Netherlands, Italy, Belgium, Austria, France, Spain, and Germany. Customers should contact Inpeco S.A. to verify if their specific units are affected and to obtain the updated safety information.
The recalled product
- Product
- FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
- Manufacturer
- Inpeco S.A.
- Affected units
- 679
Distribution
Distribution scope not specified by the agency.
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