Advia Centaur XPT Instrument

Starting date:

February 6, 2017

Posting date:

February 28, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62288

• Reason
• Affected products

Reason

All the Advia Centaur XPT System Software Versions v1.0.1 (Bundle 1.0.912 SMN 10819704), v1.0.2 (Bundle 1.0.1086 SMN 11219806), v1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656), v1.1 (Bundle 1.1.243 SMN 11221979, 11222064) and v1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813) may have the following issues which could affect the operation and workflow of the system:

1. System Status Unknown: The system may display an "unknown status", if a software error occurs due to: reagent barcode processing, missing wash packs for mitigations, processing of the aHAVM assay, during the daily cleaning or rinse operation, software processing errors.
2. Laboratory Automation System (LAS) Communication: Tubes received from the LAS may not be processed if the following conditions occur: - if the LAS is setup using custom test names, in software v1.2, the reagent status is not sent to the LAS. The LAS may not route tubes to the system for processing if the reagent status is not known. -  Due to an internal system timing error, samples may stop processing from the LAS if there is only one tube in the LAS queue and it is in the process of being indexed out just as another tube is being added.

• -3. QC profiles: If a new test is added to an existing QC profile, the new test is not added into all levels of the QC material that exist in the QC profile, the display will not show all control levels of the new test. Therefore, all controls may not be run for a new test.
   
• -4. 'No primary' error: A 'no primary' error is generated and tests are aborted under the following scenarios:  - If any bulk consumable container is removed while a test already has a no primary error, all tests for that tube will be flagged with a no primary flag. The tests will need to be re-ordered. -  If an "immediate unload" of a primary reagent pack is requested by the user and the user then requests a "cancel unload" of the same pack. When the pack is depleted, any tests scheduled for the reagent pack will be aborted and will need to be re-ordered. - If an auto-repeat is triggered and requires an auto-dilution, an error in the calculation of the reagent volume required for the dilution may determine that there is insufficient reagent volume in any of the remaining onboard packs..
   
• -5. Laboratory Information System (LIS) specification: The software does not operate according to the published LIS specification. The following are corrections to the specification:  - The order record does not follow the specification. The '^' symbol is not transmitted between the rack number and the position number under the following conditions:  - 'Send rack IDs with results' is enabled in LIS configuration.- The QC order has rack & position. - The QC sample is loaded using automation track or loaded on a rack ID whose rack number is less than 1000 (ex: '1a', '20b', 999a').  - The rack ID and position number in the query record are always sent to the LIS regardless of which mode is being used on the system.

Affected products