Z-1888-2017Class II

Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215

Name: Z-1888-2017 Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215
Creator: Remel Inc
Published: 2017-03-24
License: https://open.fda.gov/license/

Remel Inc / initiated 2017-03-24 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use... on 2017-03-24. FDA classified it as Class II and gives the reason as "Confirmed complaint of surface contamination of Listeria monocytogenes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1888-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-24
Posted: 2017-04-27
Terminated: 2017-06-06
Recalling firm: Remel Inc
Product: Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: 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: JSH Culture Media, Non-Selective And Differential
Reason for recall: Confirmed complaint of surface contamination of Listeria monocytogenes.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 3/24/2017, the recalling firm sent a recall notice to their customers explaining the reason for the recall and instructing customers to review their stock and discard any affected product. The notice also instructed customers to advise of the recall anyone they may have further distributed the recalled lot to. Attached to the recall notice is a response form which the recalling firm instructed their consignees to fill out and return.
Quantity in commerce: 1,159/100 plates/packs
Distribution: US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
Product codes and lots: 101686

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1888-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1888-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

Product code JSH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)