FDAJanuary 30, 2016device
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.
What to do
FDA enforcement status: Terminated
Brands named
merge healthcaremerge
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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