| | Class 3 Recall
Boule Con Diff US Tri Pack |  |
| Date Posted |
November 02, 2012 |
| Recall Number |
Z-0189-2013 |
| Product |
Boule Con-Diff Hematology Control
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. |
| Code Information |
Product Part 501-605, Lot #1102-575 and Lot # 1102-576
|
Recalling Firm/
Manufacturer |
Clinical Diagnostic Solutions
1800 Nw 65th Ave Ste 2
Plantation, Florida 33313-4544 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Maritza Pastoriza
954-791-1773
|
Reason for
Recall |
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (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) which is used 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 complai
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| Action |
Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328.
For questions regarding this recall call 954-791-1773. |
| Quantity in Commerce |
623 vials |
| Distribution |
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY.
Foreign: Brazil and Colombia |
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