FDAClass IIIOctober 2, 2013

ABX PENTRA Calcium CP Reagent recall

ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and…

Why was ABX PENTRA Calcium CP Reagent recalled?

HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot/Serial #(s): 014664503

Product
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and…
Recalling firm
Horiba Instruments, Inc dba Horiba Medical
Quantity
2,658 units ( 1240 US 1418 OUS )
Distribution
Worldwide Distribution - USA including the country of Canada.
Recall date
October 2, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls