Recall Z-1397-06 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Pointe Scientific, Inc.
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic.
| Date | Aug 10, 2006 (initiated Jun 9, 2006) |
| Status | Terminated |
| Reason | The reagent may be contaminated with microorganisms. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 6/9/06 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 | 890 L total, all products |
| Distribution | Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela. |
| 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 |