Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton,
FDA device recall Z-0859-2010 · posted 2010-02-25 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The firm initiated the recall due to the presence of visible contamination of the product.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LBR
- Quantity affected
- 379 sets
- Distribution
- Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.
- Date initiated
- 2009-11-10
- Date posted
- 2010-02-25
- Date terminated
- 2011-02-11
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HDL CHOLESTEROL REAGENT (K812574) | Pointe Scientific, Inc., | 1981-09-24 |