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LifeTec Elite
IT SYNERGISTICS, LLC · Model 1.0 · UDI-DI 00867268000414
MMH
Prescription
0
510(k) clearances
1,041
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-25 | ConvaTec, Inc | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. |
| 2010-06-22 | SCC Soft Computer | SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient hi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.