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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00203-1
Product Name/Description	QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRP Catalogue Number: 146521 Production Lot: HX78 Expiry Date: 24/11/2016 QuikRead go wrCRP+Hb Catalogue Number: 146255 Production Lot: HX85 Expiry Date: 31/01/2017 ARTG Number: 206301
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/02/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	Investigations into complaints received have shown that in rare cases, the tests mentioned may give either falsely low CRP resultsor the measurement flow is interrupted by the error message “Faulty Reagent Addition”. Falsely low CRP results, in general, may provide misleading information for the diagnosis, therapy and monitoring of inflammatory disorders. The reported issue in a worst case scenario may cause a delay in starting the antibiotic treatment.
Recall Action	Recall
Recall Action Instructions	The sponsor is advising users to immediately quarantine and discontinue use of kits from the affected lots. This action has been closed out on 08 Jun 2017.
Contact Information	1800 222 287