Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter

FDA device recall Z-0190-2013 · posted 2012-11-02 · Terminated

Recall details

Recalling firm

Clinical Diagnostic Solutions

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JPK

Quantity affected

901 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 Colomb

Date initiated

2011-03-24

Date posted

2012-11-02

Date terminated

2014-08-13

Location

Plantation, FL

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