Class 2 Device Recall ABBOTT TestPackPlus Strep A with On Board Controls (OBC) II

• Date Initiated by Firm: June 11, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 05, 2004
• Recall Number: Z-1048-04
• Recall Event ID: 29352
• 510(K)Number: K971522
• Product Classification: Antisera, All Groups, Streptococcus Spp. - Product Code GTZ
• Product: ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
• Code Information: List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200. List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD/GPRD; 100/200 Abbott Park Road; Abbott Park IL 60064
• Manufacturer Reason for Recall: False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
• FDA Determined Cause: Other
• Action: A Device Recall Letter was sent to customers that received the affected product lots on 6/11/04 via Federal Express Priority. The accounts were informed of the false positive readings, and were requested to destroy any affected inventory of the recalled lots.
• Quantity in Commerce: 75,368 kits
• Distribution: The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany
• 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 = GTZ