FDAClass IIApril 16, 2014

Boule Con-Diff Tri-Level Multi-Parameter Assayed recall

Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of…

Why was Boule Con-Diff Tri-Level Multi-Parameter Assayed recalled?

Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

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?

Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014

Product
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of…
Recalling firm
Clinical Diagnostic Solutions
Quantity
3,540
Distribution
Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Recall date
April 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls