Z-2764-2015 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- March 13, 2015
- Termination Date
- October 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
Code Information
Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402