510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1748-2015Class II

Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100...

Remel Inc / initiated 2015-05-04 / Terminated / root cause: manufacturing process

Remel Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Product may be contaminated with Listeria monocytogenes". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1748-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Remel Inc
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.
Product code
JSG Culture Media, Non-Selective And Non-Differential
Reason for recall
Product may be contaminated with Listeria monocytogenes.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
The recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.
Quantity in commerce
845/10/10-plate pack cases
Distribution
Nationwide Distribution.
Product codes and lots
Lot Number: 646595 and 646596 Expiration date: 19May2015

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1748-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1748-2015Class IITerminatedVoluntary: Firm initiated