—#136475

Product

Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

FDA product code: JSG — Culture Media, Non-Selective And Non-Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot Number: 646595 and 646596 Expiration date: 19May2015

Why it was recalled

Product may be contaminated with Listeria monocytogenes.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

The recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-05-04
Posted by FDA: 2015-06-10
Terminated: 2017-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.