Recall Z-0273-04 ยท LJG Quality Control Slides
Remel, Inc.
Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
| Date | Dec 25, 2003 (initiated Nov 3, 2003) |
| Status | Terminated |
| Reason | Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area |
| Root cause | Other |
| Action | Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890718 | GRAM STAIN CONTROL SLIDE Scientific Device Laboratory, Inc., Mar 16, 1989 |