Reported Nov 14, 2012 · Terminated
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of…
Clinical Diagnostic Solutions
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Lot codes and dates
Product part 501-607Lot #1005-549
- Amount recalled
- 690 packs
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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