Horiba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues
Horiba Medical is recalling ABX PENTRA Reagent Containers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.
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: The recall involves a medical device defect that could lead to incorrect diagnostic results without an alarm, posing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
Horiba Medical is recalling ABX PENTRA Reagent Containers, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL). The recall involves 443 units that were distributed nationwide in the US. These containers were manufactured since June 2014.
The recall is being issued because the containers do not always sit properly into the reagent rack. In low reagent level scenarios, this defect could lead to insufficient reagent volume being pipetted. This could result in incorrect results being reported without an alarm, specifically false high or false low results for HbA1c and false high results for magnesium.
Healthcare facilities and users of the ABX PENTRA 400 system should stop using the affected reagent containers and contact Horiba Medical for instructions on how to return or replace the product.
The recalled product
- Product
- ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Affected units
- 443
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)
- Model No. B1037307 (15 mL)
- B1034626 (10 mL)
- and B1034634 (4 mL) manufactured since June 2014.
Distribution
Distributed nationwide across the United States.
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