Reported Apr 16, 2014 · Terminated

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

Clinical Diagnostic Solutions

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: Clinical Diagnostic Solutions · 1800 Nw 65th Ave Ste 2 · Plantation, FL · 33313-4544

Is this the product you have?

  • Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Lot codes and dates
  • Product Part Number501-605 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
Amount recalled
3,540

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 7, 2014 · Data as of Sep 19, 6:50 PM UTC

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