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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00764-1
Product Name/Description 5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)

List Number: 04J71-20

Lot Numbers: 56944001, 57026001, 57059001 and 57673001
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/07/2014
Responsible Entity Abbott Australasia Pty Ltd Molecular Division
Reason/Issue Investigation at Abbott Molecular identified that some of the 5mL Reaction Vessels (RV) contained in lots 56944001, 57026001, 57059001 and 57673001 may have insufficient rim. An RV with an insufficient rim may not be held securely in the 1mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it. It is estimated that less than 1% of RVs within these lots may be defective. These lots have been in distribution since July 2012.
Recall Action Recall
Recall Action Instructions End users are advised to remove them from use any remaining RVs from lots 56944001, 57026001, 57059001, or 57673001 (original vendor lot 2198077). Replacement product will be coordinated on return of the receipt acknowledgement form.
Contact Information 1800 816 696 - Abbott Molecular Customer Support