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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model IR-500 · UDI-DI 05060500090005
1
510(k) clearances
20
Adverse events
1
Recalls
21
Facilities
Description
Automated Clinical Chemistry Analyzer IVD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-07 | HemoCue AB | Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the |
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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.