Recall record at a glance
| Official record | Z-2671-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare It |
| Report date | Sep 7, 2016 |
| Recall initiation date | Nov 20, 2012 |
| Quantity | 17 |
| Location | Barrington, IL, United States |
Official product description
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.
Why the product was recalled
The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.
Distribution information
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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