Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin R
FDA device recall Z-2586-2017 · posted 2017-06-14 · Terminated
Recall details
- Recalling firm
- Medtest Holdings, Inc.
- Reason for recall
- Decrease reactivity of R 1 component.
- Action taken
- On 3/13/2012 and 5/3/2012, Field Correction Notice notifications were sent to the affected consignees via e-mail/fax. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CIG
- Quantity affected
- 270.36 L
- Distribution
- Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
- Date initiated
- 2012-03-13
- Date posted
- 2017-06-14
- Date terminated
- 2017-07-24
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOTAL BILIRUBIN REAGENT SET (K040391) | Pointe Scientific, Inc., | 2004-06-02 |