Z-2928-2011

remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel...

Name: Z-2928-2011 remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel...
Creator: Remel Inc
Published: 2011-04-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2011-04-21 / Terminated

FDA source

Remel Inc began a recall of remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by... on 2011-04-21. The reason FDA records is "Organism strains may fail to consistently produce confluent growth". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2928-2011
Status: Terminated
Initiated: 2011-04-21
Posted: 2011-08-03
Terminated: 2013-06-21
Recalling firm: Remel Inc
Product: remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Organism strains may fail to consistently produce confluent growth
FDA root cause: Other
Action: The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.
Quantity in commerce: 223/10-pack boxes
Distribution: Nationwide distribution.
Product codes and lots: Lot 014360, Exp. 2011.04.18; Lot 020424, Exp. 2011.04.26; and Lot 025985, Exp. 2011.05.09.

Product code JSO

K892928Class IIHaemophilus Test Medium (Agar)Remel Co. / cleared 1989-06-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)