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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01090-1
Product Name/Description VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)

Product Code: 1072693

Lot Numbers: 4492 and above

Expiry: 13 Aug 2017 and later (as until this issue is resolved, future lots may be affected)

ARTG: 180199
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/08/2017
Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Reason/Issue Ortho Clinical Diagnostics (OCD) updated the reagent pack (i.e. bottle) for VITROS Signal Reagent, beginning with Lot 4492. Some customers have reported that their VITROS 3600 or 5600 System cannot detect the presence of the VITROS Signal Reagent pack when using Lot 4492 or above.

An investigation by OCD determined that sensors on the VITROS System may not detect the base of the updated VITROS Signal Reagent Packs due to a larger indentation at the base of the reagent pack. As a result, some VITROS 3600 or 5600 Systems may not be able to continually detect VITROS Signal Reagent Packs in the load positions or during testing at the in-use position.

If the sensor cannot detect the base of the pack, that pack cannot be used to process samples.
Recall Action Recall for Product Correction
Recall Action Instructions If the VITROS 3600 or 5600 System cannot detect the presence of VITROS Signal Reagent Packs, users are to contact the Ortho Care Technical Solutions Centre for immediate assistance. An Ortho trained service representative will schedule the installation of MOD C3.
Complete the Confirmation of Receipt form supplied with customer letter and if the affected lots were distributed to a different location, please forward the notification on.

This action has been closed out on 18/02/2019
Contact Information 1800 032 359 - Ortho Care Technical Solutions Centre