Home › Kunming Lianen Biotechnology Co., LTD › LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip
LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip
Kunming Lianen Biotechnology Co., LTD · Model A801 · UDI-DI 06972164410039
1
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-10 | Randox Laboratories Ltd. | Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient |
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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.