The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2003-2020·Announced 2020-05-20

Inpeco FlexLab Interface Module Recalled for Sample Cross-Contamination Risk

Inpeco S.A. is recalling 82 FlexLab Interface Modules because a timeout error could cause sample cross-contamination.

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 (sample cross-contamination) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Inpeco S.A. is recalling 82 units of the Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module (Part Numbers: FLX-208-00, FLX-208-10). The affected modules are identified by specific serial numbers listed in the recall documentation.

The recall is due to a defect where module timeout expiry errors could occur if the analyzer sample carousel lid remains open or if a manual process takes too long. These errors could cause cross-contamination of samples. The products were distributed worldwide, including nationwide in the United States.

Users should contact Inpeco S.A. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, but standard recall procedures apply.

The recalled product

Product
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
82

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)

  • Serial Numbers: AML.001
  • FLX.0104
  • FLX.0105
  • FLX.0106
  • FLX.0107
  • FLX.0108
  • FLX.0112
  • FLX.0114
  • FLX.0115
  • FLX.0116
  • FLX.0118
  • FLX.0119
  • FLX.0120
  • FLX.0124
  • FLX.0125
  • FLX.0126
  • FLX.0131
  • FLX.0133
  • FLX.0134
  • FLX.0135

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Inpeco S.A.

See all →

Same hazard · cross contamination

See all →

Similar recalls