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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00628-1
Product Name/Description Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diagnostic medical device (IVD)

Lot Numbers: 2184561, 2308897, 2228271, 2213610 & 2258333

ARTG number: 236824
(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/05/2018
Responsible Entity Thermo Fisher Scientific Australia & New Zealand
Reason/Issue An internal technical investigation by Remel Europe Ltd, part of Thermo Fisher Scientific, has determined that Thermo Scientific Remel Salmonella paratyphi A-H Stained Suspension (R30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the Instructions For Use (IFU).
Recall Action Recall
Recall Action Instructions Thermo Fisher Scientific is requesting users:-
Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if
you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.

This action has been closed out on 07/11/2018
Contact Information 08 8238 9081 - Thermo Fisher Scientific