Z-1733-2009

Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel...

Name: Z-1733-2009 Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel...
Creator: Remel, Inc
Published: 2009-05-06
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-05-06 / Terminated / root cause: labeling and UDI

FDA source

Remel, Inc began a recall of Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in... on 2009-05-06. The reason FDA records is "The plate labeling is incorrect, but the outer box labeling is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1733-2009
Status: Terminated
Initiated: 2009-05-06
Posted: 2009-08-14
Terminated: 2009-10-15
Recalling firm: Remel Inc
Product: Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
Product code: JSY Kit, Identification, Mycobacteria
Reason for recall: The plate labeling is incorrect, but the outer box labeling is correct
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.
Quantity in commerce: 118 packages
Distribution: Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.
Product codes and lots: Lot 763654, Exp. 2009.07.07

Product code JSY

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)