Horiba Medical recalls 15 ML reagent cups (B1037307) for ABX PENTRA 400/C400. Improper fit may cause incorrect test results without alarm. Stop using if you have these cups.
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 15 ML reagent cups that may not fit properly in their test machines. This could lead to incorrect test results without warning, especially when reagent levels are low.
The reagent cups may not sit correctly in the reagent rack. When reagent levels are low, this can cause insufficient reagent to be measured, leading to inaccurate test results without any alarm system triggering.
Users of ABX PENTRA 400 or PENTRA C400 blood testing machines who have the specific 15 ML reagent cup model B1037307 are affected. Laboratory staff and healthcare providers using these machines are most at risk.
Check for the model number B1037307 on the cup. These cups were sold starting August 25, 2017, with the serial number SAP 1221037307.
Look for the model number B1037307 on the cup to confirm it is recalled.
If you have the recalled model, stop using it immediately to prevent incorrect test results.
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.
Check the model number on the cup. If it is B1037307, stop using it immediately to prevent incorrect test results.
These cups were sold starting August 25, 2017.
We’ve drafted a message you can send Horiba Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0494-2018 — Horiba Medical Horiba Medical Hello, I own a Horiba Medical that is covered by recall Z-0494-2018 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.
