Pointe Scientific, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2764-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: March 13, 2015

Date Posted: September 23, 2015

Recall Number: Z-2764-2015

Event ID: 71953

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.

Status: Terminated

Product Quantity: H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated