Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap.
FDA device recall Z-2116-2017 · posted 2017-05-18 · Terminated
Recall details
- Recalling firm
- Medtest Holdings, Inc.
- Reason for recall
- A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
- Action taken
- Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- CIT
- Quantity affected
- 119.168L across All lots
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-02-15
- Date posted
- 2017-05-18
- Date terminated
- 2017-06-02
- 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 |
|---|---|---|
| LIQUID AST (SGOT)REAGENT SET (K941132) | Pointe Scientific, Inc., | 1994-05-02 |