Medical device manufacturer, Beckman Coulter Incorporation, has issued a medical device safety alert concerning its CEA Reagent Kit for UniCel DxI 800, UniCel DxI 600, UniCel DxC 600i, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, UniCel DxC 660i and Access 2 Immunoassay systems [Reference number: 33200; Lot number: 595027 (15-Feb-16), 595029 (28-Feb-16)].

The manufacturer has determined that the Access CEA reagent packs of the lots listed above were filled incorrectly. The affected packs contain insufficient quantity of reagents in one of the pack wells.

According to the manufacturer, the impact is dependent upon the instrument and software version installed at the time the reagent lot was in use:

• Access 2 systems running software version 3.3.1 or lower, and Access 2i systems running software version 6.1 or lower with these reagent lots:
  • The instrument may have generated incorrect results of 0.0 ng/mL when using an affected pack.
  • All other results greater than 0.0 ng/mL are not affected by this issue and are correct.
• Access 2 systems running software version 3.4.2 and Access 2i systems running software version 6.2.2 or higher with these lots:
  • The affected packs would have been detected by process monitoring with a result flag QSD (indicates reagent dispense is insufficient), and the pack would have been disabled by the instrument.
  • No patient result would have been generated.
• UniCel DxI systems running any software version:
  • The packs would have been detected by reagent pack monitoring with a result flag QSD, and the pack would have been disabled by the instrument.
  • No patient result would have been generated.

All users that received the affected lots listed above are advised to discard the Access CEA reagent pack lots listed above.

For Access 2 users with software version 3.3.1 or lower and Access 2i users with software version 6.1 or lower, they are advised to review their patient results that were reported as 0.0 ng/mL and did not match the clinical status of the patients.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 October 2015