KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg,

FDA device recall Z-2173-2013 · posted 2013-09-10 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MAQ

Quantity affected

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, J

Date initiated

2013-07-25

Date posted

2013-09-10

Date terminated

2015-08-06

Location

S Branchburg, NJ