FDAClass IIINovember 28, 2012

Minotrol 16 recall

Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended…

Why was Minotrol 16 recalled?

HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.

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?

Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).

Product
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended…
Recalling firm
Horiba Instruments, Inc dba Horiba Medical
Quantity
22,954
Distribution
Nationwide Distribution
Recall date
November 28, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
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