Horiba Medical recalls 10 ML Reagent Cups (B1034626) for ABX PENTRA 400/C400 systems. Improper fit may cause incorrect test results without alarms. Affected units sold from August 2017.
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
Horiba Medical is recalling 10 ML Reagent Cups used with ABX PENTRA 400/C400 blood analyzers because they sometimes don't fit properly in the reagent rack. This can cause incorrect test results without warning when reagent levels are low. Using these cups could lead to inaccurate medical testing results.
The reagent cups may not sit correctly in the reagent rack, especially when there's low reagent volume. This can cause the analyzer to report incorrect test results without triggering an alarm, potentially leading to wrong medical diagnoses.
Laboratory users who own or use the ABX PENTRA 400/C400 blood analyzers with the recalled 10 ML Reagent Cups (B1034626, SAP 1221034626) are most at risk. This affects units sold starting August 25, 2017.
Check for the model number B1034626 and serial number SAP 1221034626 on the reagent cup. These cups were sold with ABX PENTRA 400/C400 analyzers starting August 25, 2017.
Look for the model number B1034626 and serial number SAP 1221034626 on the reagent cup.
The reagent cups may not sit properly in the reagent rack, which can cause incorrect test results without an alarm when reagent levels are low.
The recall record does not specify a remedy, so no action is required at this time.
These cups were sold starting August 25, 2017, with ABX PENTRA 400/C400 analyzers.
We’ve drafted a message you can send Horiba Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2018 — Horiba Medical Horiba Medical Hello, I own a Horiba Medical that is covered by recall Z-0493-2018 from Horiba Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
