Enforcement Report - Week of November 14, 2012
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Event Detail
| Event ID | 63096 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Clinical Diagnostic Solutions |
| City | Plantation |
| State | FL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-03-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Product Part 501-605, Lot #1102-575 and Lot # 1102-576 | Class III | 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 complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. | 623 vials | Z-0189-2013 |
| Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Product Part 501-607, Lot #1102-576 | Class III | 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 complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. | 901 vials | Z-0190-2013 |
| Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Product Part 502-012, Lot #1102-574 | Class III | 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 complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. | 197 vials | Z-0191-2013 |
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