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Type of Product Medical Device
TGA Recall Reference RC-2023-RN-01066-1
Product Name/Description NeoBaseTM 2 Non-derivatized MSMS kit. An in vitro diagnostic medical device (IVD)

Product Number: 3044-0010

Lot Number: 1074373501, 1074561801, 1074875402, 1074373502, 1074583001, 1074875403, 1074383201, 1074606101, 1074875404, 1074406701, 1074650401, 1074925801, 1074492201, 1074700401, 1074925802, 1074517001, 1074723801, 1074933602, 1074517002, 1074789801, 1074933603,
1074517003, 1074851001, 1074532401, 1074875401

ARTG 199142
(Revvity Pty Ltd - Clinical chemistry substrate IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/12/2023
Responsible Entity Revvity Pty Ltd
Reason/Issue There is an inadequacy in the instructions for use for product 3044-0010. NeoBase 2 Internal Standards (IS) vial reconstitution and further Extraction Working Solution (EWS) preparation steps contain unclarity.

The extended storage of reconstituted NeoBase 2 Internal Standards vials at +2-+8 °C may possibly cause some loss of C26:0-LPC IS and/or C26 IS from solution due to their observed irreversible binding to the inner vial surface. New clarified IS vial handling instruction should be followed e.g., to avoid potential risks for elevated frequency of false positive X-ALD screening results, failed C26:0-LPC and/or C26 kit control results and resulted unnecessary test repeats.
Recall Action Product Defect Correction
Recall Action Instructions Customers are advised:
- The use of the NeoBase 2 Non-derivatized MSMS kit can continue.
- The instructed single Extraction Working Solution (EWS) should be prepared immediately after reconstitution step of NeoBase 2 Internal Standards vial.
- Do not store reconstituted Internal Standards vial. After the EWS preparation it can be used for 2 weeks when stored at +2–+8 °C protected from light.
- When not in use, store the EWS protected from light in a glass laboratory bottle with firmly sealed screw cap closure at +2–+8 °C.
Contact Information 0409560897 - Antoniette Violo, Director