—#30394

Product

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

FDA product code: LJG — Quality Control Slides
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K890718
Affected lot / code info: Lot #001453, Exp. 2013-04-03

Why it was recalled

Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area

Root cause (FDA determination)

Other

Action the firm took

Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.

Recalling firm

Firm: Remel, Inc.
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-11-03
Posted by FDA: 2003-12-25
Terminated: 2004-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30394. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.