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Terminated

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

FDA Recall Z-0273-04 · Posted 2003-12-25

Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeLJG
Date Initiated2003-11-03
Date Terminated2004-01-13
Product Quantity25 boxes

Reason for Recall

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

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc. · 1989-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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