Recall Z-0305-2007 ยท KKS Acid, Periodic
EMD Chemicals Inc
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
| Date | Dec 27, 2006 (initiated Jul 25, 2006) |
| Status | Terminated |
| Reason | Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly. |
| Root cause | Other |
| Action | On July 27, 2006 EMD contacted its direct account customers via letter. The firm requested discontinue use of the product and contact EMD for return. |
| Quantity | 74 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.