Recall Z-1114-2008
Pointe Scientific, Inc. · initiated December 14, 2007
Product
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
Codes / lots: Lots 628302-004 and 704601-113.
Reason for recall
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
FDA-determined cause: Process control
Action taken
Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.
Details
- Recall number
- Z-1114-2008
- Initiated
- December 14, 2007
- Posted by FDA
- May 22, 2008
- Terminated
- September 15, 2008
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Quantity
- 955 for all products.
- Distribution
- Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1110-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1111-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1112-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1113-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1115-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1116-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1117-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |