Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Clinical Diagnostic Solutions, Inc. in Plantation, FL, is recalling Boule Con-Diff US Tri Pack hematology control vials. The affected products include Product Part 501-605 (Lot #1102-575 and 1102-576), Product Part 501-607 (Lot #1102-576), and Product Part 502-012 (Lot #1102-574). These products are intended for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
The recall was initiated due to the receipt of a complaint. The source text does not specify the nature of the complaint or the specific defect. The recall is classified as Class III by the FDA, which indicates that the use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The affected products were distributed worldwide, including in the United States (AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV, and WY) and in Brazil and Colombia. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Manufacturer
- Clinical Diagnostic Solutions
- Hazard
- Affected units
- 901
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Part 501-607
- Lot #1102-576
Distribution
Part of a larger recall action
This product is one of 3 recalled by Clinical Diagnostic Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Clinical Diagnostic Solutions
See all →- ModerateClinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV
FDA (Devices) · 2014-04-16
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- ModerateClinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls
FDA (Devices) · 2012-11-14
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
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