Recall Z-0123-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
Ge Healthcare It
GE Centricity Laboratory Instrument Interface 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 | Oct 22, 2010 (initiated Aug 27, 2010) |
| Status | Terminated |
| Reason | Instrument may incorrectly report the result of an antimicrobial sensitivity test. |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated August 27, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue associated with the use of GE Centricity Laboratory instrument interface to Biomerieux's Vitek analyzer where results may be incorrectly reported. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any quest |
| Quantity | 22 units |
| Distribution | Worldwide Distribution -- USA, including states of Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee, and Texas and countries of Australia, Canada, England, India, New Zealand, Qatar, and Scotland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.