Recall Z-1357-2008
Pointe Scientific, Inc. · initiated February 7, 2008
Product
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific
Codes / lots: All Lots beginning with 727801; exp. 4/09.
Reason for recall
May be contaminated with microorganisms.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1357-2008
- Initiated
- February 7, 2008
- Posted by FDA
- March 27, 2008
- Terminated
- June 12, 2009
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Quantity
- 7.4 L.
- Distribution
- Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1353-2008 | Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1354-2008 | Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1355-2008 | Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1356-2008 | Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1358-2008 | Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos.…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1359-2008 | Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos.…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1360-2008 | Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic…May be contaminated with microorganisms. | 02/07/2008Terminated |