Recall Z-0860-2010 ยท LBR Ldl & Vldl Precipitation, Hdl
Pointe Scientific, Inc.
Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.
| Date | Feb 25, 2010 (initiated Nov 10, 2009) |
| Status | Terminated |
| Reason | The firm initiated the recall due to the presence of visible contamination of the product. |
| Root cause | Process control |
| Action | Consignees were notified by an Urgent: Medical Device Recall letter (sent by email, fax or through the mails) dated 11/10/09. The letter identified the affected product and instructed customers to immediately examine their inventory. If the product was further distributed their customers should be identified and notified of the recall. Customers are instructed to dispose of any product in stock. Questions should be directed to the Technical Support Department at 800-757-5313 or 734-487-8300. |
| Quantity | 237 sets plus 9L |
| Distribution | Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812574 | HDL CHOLESTEROL REAGENT Pointe Scientific, Inc.,, Sep 24, 1981 |