Horiba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues
Horiba Medical is recalling ABX PENTRA reagent cups that 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 a risk of incorrect diagnostic results without an alarm, which fits the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Horiba Instruments, Inc dba Horiba Medical is recalling 10 ML REAGENT CUPS (B1034626, SAP 1221034626) intended for use with ABX PENTRA 400 and PENTRA C400 analyzers. The recall involves 10 bags containing 100 units each, distributed nationwide. The specific lot identified has a date code of MVT 25.08.2017.
The recall was initiated because the reagent containers do not always sit properly into the reagent rack. In scenarios where reagent levels are low, this improper fit could lead to insufficient reagent volume being pipetted. Consequently, the device may report incorrect results without triggering an alarm.
Healthcare facilities and users of the ABX PENTRA 400 or PENTRA C400 systems should check their inventory for the affected product codes and date codes. Users should stop using the affected reagent cups and contact Horiba Medical for instructions on how to return or replace the product.
The recalled product
- Product
- 10 ML REAGENT CUP, B1034626, SAP 1221034626 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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