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Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL)
HORIBA INSTRUMENTS INCORPORATED · Model 60-TH0152-5 · UDI-DI 00811727017338
DLJ
Prescription
1
510(k) clearances
21
Adverse events
5
Recalls
40
Facilities
Description
Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers. The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
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.