| 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 |
|
| 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 |