Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, L
FDA device recall Z-2303-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- EMD Chemicals Inc
- Reason for recall
- Two complaints that kit was not performing properly with positive controls.
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- HZT
- Quantity affected
- 29 kits
- Distribution
- Nationwide.
- Date initiated
- 2008-06-02
- Date posted
- 2008-09-20
- Date terminated
- 2008-09-22
- Location
- Gibbstown, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.