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.
This recall has been terminated (originally issued September 20, 2008).
- Company
- Emd Chemicals Inc
- Recall Initiated
- June 2, 2008
- Posted
- September 20, 2008
- Terminated
- September 22, 2008
- Recall Number
- Z-2303-2008
- Quantity
- 29 kits
- Firm Location
- Gibbstown, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Two complaints that kit was not performing properly with positive controls.
Distribution
Nationwide.
Lot / Code Info
Item number 64945/93; Lot # 8055, Exp. August 31, 2009.
Root Cause
Process control
Action Taken
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
More recalls by Emd Chemicals Inc
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbsto...
Oct 12, 2011
EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;
1.0 mg Ethanol in 1 ml, 10 ampules; Item n...
Sep 16, 2008
Harleco
May and Grunwald's Stain;
0.17% w/v;
Methanol Solution UN1230;
EMD Chemicals Inc.
An Affilif...
Nov 3, 2007