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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model H7512-STD · UDI-DI 00811727011459
LBR
Prescription
1
510(k) clearances
26
Adverse events
11
Recalls
40
Facilities
Description
Reagent intended for use as an cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol assays used with HDL Cholesterol procedures 1 x 15ml
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-10 | Medtest Holdings, Inc. | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. |
| 2016-07-20 | Sterling Diagnostics, Inc. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine |
| 2015-03-13 | Pointe Scientific, Inc. | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. |
| 2009-11-10 | Pointe Scientific, Inc. | The firm initiated the recall due to the presence of visible contamination of the product. |
| 2009-11-10 | Pointe Scientific, Inc. | The firm initiated the recall due to the presence of visible contamination of the product. |
| 2009-01-29 | Pointe Scientific, Inc. | The R1 reagent has microbial contamination. |
| 2009-01-29 | Pointe Scientific, Inc. | The R1 reagent has microbial contamination. |
| 2006-09-18 | Stanbio Laboratory, Inc | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| 2006-09-18 | Stanbio Laboratory, Inc | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
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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.