Recall Z-1359-2008 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Pointe Scientific, Inc.
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.
| Date | Mar 27, 2008 (initiated Feb 7, 2008) |
| Status | Terminated |
| Reason | May be contaminated with microorganisms. |
| Root cause | Other |
| Action | 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. |
| Quantity | 47 |
| Distribution | Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET Pointe Scientific, Inc.,, Oct 22, 1997 |