Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.
FDA device recall Z-1355-2008 · posted 2008-03-27 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- May be contaminated with microorganisms.
- Action taken
- Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
- Root cause
- Other
- Status
- Terminated
- Product code
- CJE
- Quantity affected
- 1
- Distribution
- Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
- Date initiated
- 2008-02-07
- Date posted
- 2008-03-27
- Date terminated
- 2009-06-12
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588) | Pointe Scientific, Inc., | 1997-10-22 |