Z-2137-2018Class II

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN

Name: Z-2137-2018 remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN
Creator: Thermo Fisher
Published: 2018-05-04
License: https://open.fda.gov/license/

Remel Inc / initiated 2018-05-04 / Terminated

FDA source

Thermo Fisher began a recall of remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to... on 2018-05-04. FDA classified it as Class II and gives the reason as "Product may fail performance testing for S aureus ATCC 43300". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2137-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-06-08
Terminated: 2018-12-19
Recalling firm: Remel Inc
Product: remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: Product may fail performance testing for S aureus ATCC 43300.
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 05/04/2018. The letter stated the following: "Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action." For questions contact Technical Services Department at 800-255-6730 or 913-888-0939.
Quantity in commerce: 67 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot: 307200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-08

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)