Laboratory automation recalled over sample tubes with mismatched labels
Inpeco is recalling 14 FlexLab systems because the aliquoter module may produce secondary sample tubes without labels or with mismatched labels.
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-217-40, 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 recall covers 14 units, of which the record lists 1 in the United States and 13 outside it, carrying UDI-DI 07640172344002, across serial numbers including FXX.0004, FXX.0006, FXX.0009, FXX.0022 and FXX.0023. Distribution included Michigan domestically and internationally Australia, Finland, France, Germany, Italy and Portugal. 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-217-40;
- 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 (15)
- UDI-DI: 07640172344002
- Serial number: FXX.0004
- FXX.0006
- FXX.0009
- FXX.0022
- FXX.0023
- FXX.0024
- FXX.0027
- FXX.0028
- FXX.0034
- FXX.0036
- FXX.0041
- FXX.0042
- FXX.0043
- FXX.0046
Distribution
Distributed in 1 state:
- MI
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