Z-0792-2013Class III

Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the...

Name: Z-0792-2013 Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the...
Creator: Diagnostic Hybrids Inc
Published: 2012-12-31
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-12-31 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids Inc began a recall of Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as... on 2012-12-31. FDA classified it as Class III and gives the reason as "RhMK product fungal contamination". 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-0792-2013
Classification: Class III
Status: Terminated
Initiated: 2012-12-31
Posted: 2013-02-07
Terminated: 2013-12-05
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
Product code: LKA Culture Media, Antimicrobial Susceptibility Test
Reason for recall: RhMK product fungal contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Diagnostic Hybrids sent a Urgent: Medical Device Recall letter dated December 31, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to immediately review your inventory and determine if you have any of the affected product. If so, please remove it from inventory. Complete the enclosed Product Recall Fax-Back form. Upon receipt of Fax-Back form, Diagnostic Hybrids will send you replacement product or issue credit. Representatives are available to assist you in this process and answer any questions you may have about this recall, and how to obtain replacement product. Please contact Technical Support at [email protected] or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Quantity in commerce: 13,005 units
Distribution: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.
Product codes and lots: Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 and Model #: 49-T075A, Lot#, -A-491206T, -A-491216.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0792-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0792-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-07

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)