Recalling Firm / Manufacturer

Roche Diagnostics Ltd

Product

COBAS AmpliPrep R-Tip: cobas s 201 R-Tip , cobas s 401 R-Tip

Description

The COBAS AmpliPrep Instrument automates the sample preparation steps of PCR testing for analysis on the COBAS AMPLlCOR Analyzer or COBAS TaqMan Analyzers. The cobas s 201 system is a system for nucleic acid testing (NAT) for blood screening laboratories. The cobas s 401 System, which is used in Japan, utilizes the same cobas TaqScreen MPX Test reagents used on the cobas s 201 System.

Code Information

Model: COBAS AmpliPrep R-Tip (28173362001); cobas s 201 R-Tip (28173362001); cobas s 401 R-Tip (04792564001, 04704797001).

Lot/Batch no. : COBAS AmpliPrep and cobas s 201 R-Tip: 470266-483672; cobas s 401 R-Tip: all cobas s 401 R-Tips not replaced since August 2009

Reason of Recall

The manufacturer has noticed reagent tips (R-tips) with cracked grey holders. The function of the R-tips is to aspirate and dispense reagents. The investigations of the issue showed that cracked R-tips might cause initialization problems showing a system error ("level detection problem init" followed by a second message "Restart instrument"). If this occurs the run cannot be started or the run is aborted. The data of an aborted run are shown as invalid results.

Date Recall Initiated

February 02, 2010

Action

The manufacturer's root cause analysis showed that the cracks in the R-Tips arose because of modifications in the polymer raw material of the tips, leading to reduced resistance of the grey holders of the R-tips. Corrective actions have been implemented at the supplier of the raw material. According to Roche Diagnostics Ltd there is no indication that cracked R-Tips could lead to wrong results. Defective R-tips, however, might be responsible for delayed results. Therefore, the manufacturer has decided to replace all affected tips at customer and affiliate sites. Roche Diagnostics Ltd advised that the substitution of these R-Tips in the market is already on-going. The manufacturer also advised that the action will take several months due to the high number of active instruments in the field, that, however, Roche Diagnostics Ltd has defined a priority for blood screening customers. 

Contact

FAROUK, MAAMOUN TAMER & COMPANY
Riyadh
(01) 4142200

Source of Information

NCAR

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.