Laboratory automation recalled over unlabelled or mismatched secondary sample tubes
Inpeco is recalling a FlexLab system because the aliquoter module may produce secondary sample tubes without labels or with mismatched labels, risking delayed or erroneous results.
What this means for you
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: Scored 3 under the risk-of-harm criterion: mismatched sample labels can produce erroneous results attributed to the wrong patient, and no injuries are reported.
Plain-English summary
The Inpeco FlexLab (FLX), version FLX-217-10, is being recalled.
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels, which the firm states may result in delayed results or erroneous results. The error occurs if operators open the printer head of the mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
The record lists 1 unit, outside the United States only, carrying UDI-DI 07640172340004, serial number FLX.0226. Distribution included Michigan domestically and internationally Australia, Finland, France, Germany, Italy, Portugal, Spain and the United Kingdom. The FDA has classified the action as Class II.
A mismatched label attaches a sample to the wrong patient. Laboratories operating an affected system should follow Inpeco's instructions.
The recalled product
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Manufacturer
- Inpeco S.A.
- Hazard
- mislabeled-samples
- erroneous-results
- delayed-results
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)
- UDI-DI: 07640172340004 Serial number: FLX.0226
Distribution
Distributed in 1 state:
- MI
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