Z-0644-2010

remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is...

Name: Z-0644-2010 remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is...
Creator: Remel, Inc
Published: 2009-12-08
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-12-08 / Terminated / root cause: manufacturing process

FDA source

Remel, Inc began a recall of remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium... on 2009-12-08. The reason FDA records is "The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591". 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-0644-2010
Status: Terminated
Initiated: 2009-12-08
Posted: 2010-01-15
Terminated: 2011-07-12
Recalling firm: Remel Inc
Product: remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).
Quantity in commerce: 267 units
Distribution: Nationwide.
Product codes and lots: Lot Number 833352, Exp. 2009.12.22.

Product code JTZ

K850291Class IIMueller Hinton Agar W/4% Nacl W/antibioticsRemel Co. / cleared 1985-05-10

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)