Inpeco Laboratory Automation Systems Recalled for Module Freezing Risk
Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.
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 is classified as FDA Class II. The hazard involves a delay in patient test results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Inpeco S.A. is recalling 18 units of its FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2) Laboratory Automation Systems. The recall involves specific serial numbers for the Accelerator a3600, FlexLab, and Aptio Automation units, as well as specific part numbers for impacted sample tube carriers. These products were distributed to distributors in New York and Illinois.
The recall is being issued because a module within the systems may freeze without generating a user warning. This malfunction poses a potential risk of delaying sample processing, which could lead to delayed delivery of test results to patients.
Healthcare facilities and laboratories that have purchased these specific units should contact Inpeco S.A. for further instructions on how to address the issue. The source text does not specify a particular action for end-users, but the delay in results is the primary concern for patient care.
The recalled product
- Product
- FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
- Manufacturer
- Inpeco S.A.
- Affected units
- 18
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 (1)
- and 0A00006957 for 40 mm carriers
Distribution
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