Class 2 Device Recall Remel QCSlide Gram Stain Control

• Date Initiated by Firm: November 03, 2003
• Date Posted: December 25, 2003
• Recall Status: Terminated on January 13, 2004
• Recall Number: Z-0273-04
• Recall Event ID: 27713
• 510(K)Number: K890718
• Product Classification: Quality Control Slides - Product Code LJG
• Product: Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
• Code Information: Lot #001453, Exp. 2013-04-03
• Recalling Firm/ Manufacturer: Remel, Inc.; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Robert Booth; 913-895-4007
• Manufacturer Reason for Recall: Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
• FDA Determined Cause: Other
• Action: Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.
• Quantity in Commerce: 25 boxes
• Distribution: Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJG