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LDL-Cholesterol Gen.3
Roche Diagnostics GmbH · Model 07005768190 · UDI-DI 04015630934591
LBR
Prescription
1
510(k) clearances
26
Adverse events
11
Recalls
39
Facilities
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.