Recall Z-2303-2008 ยท HZT Reagent, Schiff
EMD Chemicals Inc
Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.
| Date | Sep 20, 2008 (initiated Jun 2, 2008) |
| Status | Terminated |
| Reason | Two complaints that kit was not performing properly with positive controls. |
| Root cause | Process control |
| Action | Distributors were notified of the recall on June 4, 2008 by e-mail, followed by a letter. The letter dated June 4, 2008, describes the problem, instructs customers to discontinue use of the product and contact EMD Chemicals for product replacement. An Important Product Recall form was also included in each letter, asking that the form be completed and returned to EMD. Contact EMD Chemicals Technical Service Department at 1-800-222-0342.A |
| Quantity | 29 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.