ORTHO VISION Analyzer (2015-04-28)

Starting date:

April 28, 2015

Posting date:

May 26, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53493

• Reason
• Affected products

Recalled Products

A. ORTHO VISION Analyzer

Reason

Ortho Clinical Diagnostics (OCD) has identified four (4) software anomalies in the ORTHO VISION Analyzer software version 1.2.2 that will be mitigated by either a future software version release or by a system modification that will be installed by OCD service personnel. The anomalies are described below:

(1) information for different patients can be associated with one sample ID if the patient information is entered manually. If this anomaly is undetected by the operator, misassociated results may occur. Users are being reminded to be cautious when manually entering and modifying patient information associated with a sample ID. A future software version will mitigate this issue by disabling manual inputting and manual editing of patient demographics information.

(2) if a partially processed ID-MTS gel card (not yet centrifuged) has been placed in the manual review rack after a shutdown and then moved manually to the load area of the dual purpose drawer for reuse, the punched columns of the partially processed card can potentially be reused to generate results when the card is reintroduced to the system. If this anomaly occurs undetected, incorrect results may be reported. To prevent the reuse of partially used ID-MTS gel cards, users are being instructed not to manually reintroduce partially used cards to the ORTHO VISION Analyzer. A future software version will mitigate this issue by disabling the load area of the dual purpose drawer.

(3) under conditions where the user may not follow the prompt wizard when performing daily maintenance, the system will not present an error code if NaOH and 7% BSA are placed in the wrong positions, or if one type of solution is omitted in error (i.e., NaOH or 7% BSA is placed in both positions). Placing NaOH and 7% BSA vials in the wrong position or loading only one type of solution in both positions could lead to inefficient probe decontamination and conditioning, which can potentially contribute to sample carryover. Carryover can potentially lead to erroneous test results. Users are being reminded to strictly follow the prompt wizard when performing daily maintenance, and verify that NaOH and 7% BSA vials are loaded in the following manner: a. NaOH containing a barcode label and placed in position 3 b. 7% BSA not containing a barcode label and placed in position 2. A future software version will mitigate this issue by posting a 'barcode reading failed error' code if no barcode label is found on the NaOH vial placed in position 3.

(4) the analyzer is designed to automatically delete specific data at pre-established intervals as part of routine system database clean-up. Internal testing confirmed that six months after the first sample was processed, when the analyzer performs a routine system database clean-up, the software anomaly will occur, causing an error code (APSW13 or APSW00) to be generated. If the anomaly occurs, the analyzer will become inoperable. Service would be required to restore operation. To mitigate this issue, OCD will implement a modification performed by OCD service personnel to prevent occurrence of this anomaly on the ORTHO VISION Analyzer for six months. A future software version, which restores the ability to retrieve data on the analyzer is in development and users will be notified upon availability.

Affected products