Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufa
FDA device recall Z-1389-06 · posted 2006-08-10 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The reagent may be contaminated with microorganisms.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CJE
- Quantity affected
- 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, Polan
- Date initiated
- 2006-06-09
- Date posted
- 2006-08-10
- Date terminated
- 2007-11-19
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588) | Pointe Scientific, Inc., | 1997-10-22 |