Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitr
FDA device recall Z-0899-06 · posted 2006-05-25 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
- Action taken
- A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CFR
- Quantity affected
- 269 kits
- Distribution
- Nationwide.
- Date initiated
- 2006-04-12
- Date posted
- 2006-05-25
- Date terminated
- 2006-10-16
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HITACHI 704 (K854025) | Boehringer Mannheim Corp. | 1985-10-28 |