Exact FDA event identifier

Event 67415

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 24, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Remel Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.

Z-1112-2014

Recall number: Z-1112-2014
Initiated: January 24, 2014
Classification: Class II
Status: Terminated
Recalling firm: Remel Inc
Quantity: 44/10/500-ml. vial boxes

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product may contain high levels of microbial contamination

Code information

Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015

Distribution pattern

US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.