Z-0273-04

Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is...

Name: Z-0273-04 Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is...
Creator: Remel, Inc.
Published: 2003-11-03
License: https://open.fda.gov/license/

Remel Inc / initiated 2003-11-03 / Terminated

FDA source

Remel, Inc. began a recall of Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS on 2003-11-03. The reason FDA records is "Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0273-04
Status: Terminated
Initiated: 2003-11-03
Posted: 2003-12-25
Terminated: 2004-01-13
Recalling firm: Remel Inc
Product: Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
Product code: LJG Quality Control Slides
Reason for recall: Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
FDA 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 in commerce: 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.
Product codes and lots: Lot #001453, Exp. 2013-04-03

Product code LJG

K890718Class IGram Stain Control SlideScientific Device Laboratory, Inc. / cleared 1989-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)