Recall Z-2067-2010 ยท JQP Calculator/Data Processing Module, For Clinical Use
Ge Healthcare It
GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.
| Date | May 26, 2010 |
| Status | Terminated |
| Reason | There is a potential safety issue associated with the use of GE Centricity Laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in the result field. |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated May 26, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue involving results from interfaced external reference laboratories that are not displayed or stored correctly if an unexpected alpha character is encountered in a result message that is expected to have a numeric value. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the result sent from the reference lab includes a comma in the r |
| Quantity | 37 units |
| Distribution | Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.