Recalls for Ldl & Vldl Precipitation, Hdl

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.

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.

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 samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

The firm initiated the recall due to the presence of visible contamination of the product.

The firm initiated the recall due to the presence of visible contamination of the product.

The R1 reagent has microbial contamination.

The R1 reagent has microbial contamination.

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

Vials of the autoHDL/LDL Calibrator were shipped without a vial label.