ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX 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).
FDA Recall Z-2692-2014 · Posted 2014-09-24
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Recalling FirmHoriba Instruments, Inc dba Horiba Medical
Recall StatusTerminated
Product CodeJGJ
Date Initiated2014-08-11
Date Terminated2014-11-25
Product Quantity359 units
Reason for Recall
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.
Firm Action
Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266.
Root Cause
Other
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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