Recall Z-2764-2015— Pointe Scientific, Inc.

Name: FDA recall Z-2764-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class III · Terminated

Class III FDA medical device recall by Pointe Scientific, Inc., initiated 2015-03-13, terminated 2015-10-29. It names one FDA 510(k) clearance: K992002. 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.. 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..

Recalling firm: Pointe Scientific, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-03-13
Terminated: 2015-10-29
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K992002 — AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,·cleared 1999-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.