The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0087-2022·Announced 2021-10-20

Automation System Interface Module Firmware May Misassociate Test Results to Samples

Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient 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: FDA Class II recall of a firmware defect that could cause incorrect patient laboratory results. The hazard is risk-of-harm to patients without reported injuries or illnesses, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Inpeco S.A. is recalling the ADVIA Centaur XP/XPT Automation System Interface Module in certain units. These devices are marketed under three brand names—FlexLab, Accelerator a3600, and Aptio Automation—and specific serial numbers are identified in the recall notice.

A firmware defect in the module may cause test results to be incorrectly associated with sample IDs. This misassociation, combined with improper sample management, could lead to incorrect patient results. Such errors could result in inaccurate laboratory data being reported to clinicians.

The recall affects 262 units globally, including 52 in the United States. These automated laboratory systems are in domestic and international distribution.

The recalled product

Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard

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 (3)

  • Impacted Module: ADVIA Centaur XP/XPT Interface Module
  • Part No. FLX-021-00
  • FLX-021-10

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Inpeco S.A.

See all →

Same hazard · sample misidentification

See all →

Similar recalls