Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive Wes
FDA device recall Z-0743-2013 · posted 2013-01-28 · Terminated
Recall details
- Recalling firm
- Alfa Wassermann, Inc.
- Reason for recall
- Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
- Action taken
- Alfa Wassermann sent an important advisory notice/product response form to their distributors on October 10, 2012. The letter identified the product, the problem, and the action to be taken by the customer. The letter informs customers about the affected lot and provide instruction regarding the receipt of replacement product. Any recalled product should be destroyed. If there is further distribution, those customers should provide Alfa with a distribution list so that they may be notified. Any questions can be directed to (866) 419 - 2532.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CEO
- Quantity affected
- 4,104 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
- Date initiated
- 2012-10-10
- Date posted
- 2013-01-28
- Date terminated
- 2013-10-25
- Location
- W Caldwell, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615) | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 |