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Filled Vial, Lambda Exonuclease
BIOARRAY SOLUTIONS LTD · Model 800-00195 · UDI-DI 10888234100683
PEP
Prescription
0
510(k) clearances
261
Adverse events
1
Recalls
2
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-15 | Luminex Corporation | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. |
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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.