Z-1742-2019Class II

MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in...

Name: Z-1742-2019 MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in...
Creator: Bio-Rad Laboratories, Inc
Published: 2018-06-08
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2018-06-08 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc began a recall of MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data... on 2018-06-08. FDA classified it as Class II and gives the reason as "Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies". 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-1742-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2019-06-06
Terminated: 2020-10-30
Recalling firm: Bio-Rad Laboratories Inc.
Product: MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm. Bio-Rad laboratories, Inc., issued an "URGENT PRODUCT CORRECTION" letter dated 6/7/2018 to all customers via FedEx on 6/7-8/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " As already recommended in the package insert, please ensure that exposure of agar plates to light is minimized, both before and during incubation, with the added time restriction of no more than 2 hours during storage, warming, incubation, and reading. " Do not use agar with a change in color from white to an orange-pinkish shade. " As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or PASTOREX STAPH-PLUS. Please feel free to contact Technical Support with any questions or concerns at 1-800-224-6723, option #2 and then #3.
Quantity in commerce: 5,212 units
Distribution: US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.
Product codes and lots: Lot numbers 64179161, exp. 6/8/2018; 64180987, exp. 6/15/2018; 64182474, exp. 6/23/2018; 64184888, exp. 6/30/2018; 64187551, exp. 7/6/2018; 64189117, exp. 7/13/2018; 64190797, exp. 7/22/2018; and 64192125, exp. 8/3/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1742-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1743-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06

Product code JSO

K081212Class IIMrsaselect - Extended IncubationBio-Rad / cleared 2008-06-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)