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.
Recall
- Recall Number
- Z-2303-2008
- Event Number
- 48640
- Firm
- EMD Chemicals Inc
- FEI Number
- 2244894
- Product Code
- HZT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 2, 2008
- Posted
- September 20, 2008
- Terminated
- September 22, 2008
- Address
- 480 S Democrat Rd, Gibbstown, NJ, 08027-1239
Description
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.
Two complaints that kit was not performing properly with positive controls.
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
Nationwide.
29 kits