Reported Oct 1, 2014 · Terminated
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated…
Horiba Instruments, Inc. dba Horiba Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Horiba Instruments, Inc dba Horiba Medical · 34 Bunsen · Irvine, CA · 92618-4210
Is this the product you have?
- ABX PENTRA Magnesium RTU Reagent, Part No
- A11A01646 Product UsageABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium)
- Lot codes and dates
- All Lots
- Amount recalled
- 359 units
Where it was sold
- Nationwide
Why it was recalled
Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.
This product could cause temporary or reversible health problems — stop using it.
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