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Immunalysis
IMMUNALYSIS CORP · Model 10049-10 · UDI-DI 00840937103289
DLJ
Prescription
10
510(k) clearances
21
Adverse events
5
Recalls
40
Facilities
Description
Cannabinoid Oral Fluid Calibrator 3
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-14 | Ortho-Clinical Diagnostics, Inc. | Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing |
| 2014-02-06 | Lin-Zhi International Inc | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards t |
| 2011-11-11 | Microgenics Corp | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| 2011-06-08 | Microgenics Corp | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |
| 2010-09-13 | Abbott Laboratories | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. |
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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.