Recall Z-2764-2015 ยท LBR Ldl & Vldl Precipitation, Hdl
Pointe Scientific, Inc.
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
| Date | Sep 14, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313. |
| Quantity | H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits |
| Distribution | Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc.,, Aug 5, 1999 |