Z-1400-2017Class II

Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033

Name: Z-1400-2017 Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033
Creator: Remel Inc
Published: 2017-02-09
License: https://open.fda.gov/license/

Remel Inc / initiated 2017-02-09 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033 on 2017-02-09. FDA classified it as Class II and gives the reason as "Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests". 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-1400-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Posted: 2017-03-03
Terminated: 2019-05-01
Recalling firm: Remel Inc
Product: Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Product code: LKA Culture Media, Antimicrobial Susceptibility Test
Reason for recall: Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm. If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International) For further questions, please call (913) 895-4077.
Quantity in commerce: RO4033 - 163, R01503 - 50.
Distribution: USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.
Product codes and lots: A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1400-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code LKA

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)