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Cardiac Marker Control
MORE DIAGNOSTICS INC · Model 150 · UDI-DI 00856743007017
JJT
Prescription
1
510(k) clearances
18
Adverse events
2
Recalls
15
Facilities
Description
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-07-19 | Abbott Point Of Care Inc. | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12 |
| 2003-01-08 | PerkinElmer LIfe Sciences Inc | The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed. |
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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.