SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel D
FDA device recall Z-1432-2012 · posted 2012-04-16 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
- Action taken
- Beckman Coulter mailed a Product Corrective Action (PCA) Letter on April 13, 2009 dated April 10, 2009 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue use and discard appropriately the lot number(s) of the affected product and contact their Customer Service Representative at (800) 526-3821 (US), or (800)463-7828 for reagent replacement. Customers were instructed to complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain records. Customers were told to call the Customer Support Center (Hotline) at (800) 854-3633 with any questions regarding the PCA letter.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- JIF
- Quantity affected
- 3,388 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Canada
- Date initiated
- 2009-03-26
- Date posted
- 2012-04-16
- Date terminated
- 2012-04-18
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402) | Beckman Coulter, Inc. | 1999-01-29 |