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LDL Cholesterol Reagent Set

CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model R1 x 2 x 70mL, R2 x 1 x 50mL · UDI-DI 00812137012074

510(k) clearances

Adverse events

Recalls

Facilities

Description

The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

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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Data 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.