Class 3 Device Recall ProSpecT Campylobacter Microplate Assay

• Date Initiated by Firm: July 15, 2002
• Date Posted: August 17, 2004
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-1372-04
• Recall Event ID: 29672
• 510(K)Number: K982315
• Product Classification: Campylobacter Spp. - Product Code LQP
• Product: ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
• Code Information: Lot #910718
• FEI Number: 1924669
• Recalling Firm/ Manufacturer: Remel, Inc.; 12076 Santa Fe Trail Dr; (PO Box 14478, zip 66285-4478); Lenexa KS 66215-3519
• Manufacturer Reason for Recall: A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
• FDA Determined Cause: Other
• Action: Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
• Quantity in Commerce: 382
• Distribution: Entire lot was shipped to one customer in Russelsheim, 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 = LQP