Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa,
FDA device recall Z-0273-04 · posted 2003-12-25 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
- Action taken
- Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJG
- Quantity affected
- 25 boxes
- Distribution
- Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.
- Date initiated
- 2003-11-03
- Date posted
- 2003-12-25
- Date terminated
- 2004-01-13
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAM STAIN CONTROL SLIDE (K890718) | Scientific Device Laboratory, Inc. | 1989-03-16 |