Z-0769-2021Class II

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

Name: Z-0769-2021 Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Creator: Remel Inc
Published: 2020-12-10
License: https://open.fda.gov/license/

Remel Inc / initiated 2020-12-10 / Terminated

FDA source

Remel Inc began a recall of Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 on 2020-12-10. FDA classified it as Class II and gives the reason as "The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0769-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Posted: 2021-01-14
Terminated: 2023-07-06
Recalling firm: Remel Inc
Product: Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Product code: JSI Culture Media, Selective And Differential
Reason for recall: The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
FDA root cause: Mixed-up of materials/components
Action: The recalling firm issued a recall notification letter dated 12/16/2020 to all impacted customers. The letter states that all impacted product has since expired on 12/10/2020. Customers are asked to review of reported test results should be determined by the appropriate technical expert. Customers are also asked to keep the notification letter on file. The notice should be passed on to all who need to be aware within the organization or to any organization where the potentially affected products have been transferred. Questions may be directed to the Technical Services Department at 1-800-255-6730 (US) or via email: [email protected].
Quantity in commerce: 637 units
Distribution: Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
Product codes and lots: Lot 150237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0769-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0769-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-14

Product code JSI

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)