Device product
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Z-2764-2015
Product summary
- Event
- Event 71953
- Status
- Terminated
- Classification
- Class III
- Quantity
- H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
- Official record key
device-enforcement:Z-2764-2015
Official wording
Reason: 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.
Code information: Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
Distribution pattern: Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
Derived failure modes
-
Unknown
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.