Class 2 Device Recall Roche Molecular Diagnostics Inc.

• Date Initiated by Firm: January 06, 2014
• Date Posted: February 26, 2014
• Recall Status: Terminated on August 07, 2014
• Recall Number: Z-1111-2014
• Recall Event ID: 67441
• 510(K)Number: K110923
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas PCR Female Swab Kit, cobas PCR Urine kit, and cobas PCR media 100 T kit. -The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas CT/NG Test. - The cobas PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas CT/NG Test.
• Code Information: K110923 cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884) IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 Us Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: Mr. Vincent C. Stagnitto; 908-253-7200
• Manufacturer Reason for Recall: Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from different lots of the cobas PCR Urine kits, cobas PCR Female Swab kits, and cobas PCR media kits.
• FDA Determined Cause: Device Design
• Action: Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction letter/Fax-back form dated January 6, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the test-skpecific Instruction For Use for handling of cobas PCR media 4.3 ml IVD. The use of protective equipment should be worn as indicated in the labeling. Inspection each tube and/or blister packet for evidence of leakage prior to use. If leakage of the cobas PCR media 4.3 mL IVD is observed, do not use the tubes. Discard the affected tubes per local guidelines and contact Roche Support Network Customer Support Center at 1-800-526-1247. Complete the attached fax form and fax it to 1-855-695-8564. File this Urgent Medical Device Correction (UMDC) for future reference. Customers with questions were instructed to call 1-800-526-1247. For questions regarding this recall call 908-253-7200.
• Quantity in Commerce: 84 kit batches
• Distribution: Nationwide Distribution
• 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 = OOI