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U.S. Department of Health and Human Services

Class 2 Device Recall KIT cobas 4800 HPV AMP/DET 240T / 960T USIVD, CEIVD

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 Class 2 Recall
KIT cobas 4800 HPV AMP/DET 240T / 960T USIVD, CEIVD
see related information
Date Posted September 10, 2013
Recall Status1 Open
Recall Number Z-2173-2013
Recall Event ID 66036
Premarket Approval
PMA Number
P100020
Product Classification Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
Product KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas® HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas® HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas® HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas® HPV Test include the following liquid based collection media and collection device: " ThinPrep® Pap TestTM PreservCyt® Solution " Endocervical Brush/Spatula
Code Information US-IVD: Material number 05232880190 Lot Number R13814, R15785 CE-IVD: Material Number: 05235898190 05235898190 05235901190 05235910190 Lot Number R15771, R15304
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Roche Molecular Diagnostics Tech Support
800-526-1247
Manufacturer Reason
for Recall
During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
FDA Determined
Cause 2
DESIGN: Device Design
Action Roche Molecular Diagnostics sent an Urgent Medical Device Correction letter dated July 25, 2013, to all affected customers via UPS return receipt. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. Immediately discontinue use of the product lots listed above. 2. Discard affected product according to local guidelines. 3. To receive replacement inventory, complete the entire attached faxback form and fax it to 1-866-918-8741. 4. The faxback form must be completed and returned even if you do not have affected inventory. 5. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact Roche Molecular Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-526-1247, if you have questions about the information contained in this UMDC.
Quantity in Commerce US-IVD: 350 Kits; CE-IVD: 441 KITS
Distribution Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MAQ and Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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