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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