Horiba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues
Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers 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 is classified as FDA Class II. The hazard involves incorrect test results without an alarm, which poses a risk of harm to patients due to diagnostic error, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Horiba Instruments, Inc dba Horiba Medical is recalling 15 mL Reagent Cups (B1037307, SAP 1221037307) intended for use with ABX PENTRA 400 and PENTRA C400 analyzers. The recall involves 10 bags of 100 units with a date code of MVT 25.08.2017. The products were distributed nationwide.
The recall was initiated because the reagent containers do not always sit properly into the reagent rack. In scenarios with low reagent levels, this fit issue could lead to insufficient reagent volume being pipetted. Consequently, the analyzers may report incorrect results without triggering an alarm.
Healthcare facilities and users of the affected ABX PENTRA systems should stop using the recalled reagent cups and contact Horiba Medical for instructions on replacement or return. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
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)
- DATE - MVT 25.08.2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Horiba Instruments, Inc dba Horiba Medical 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
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