Z-1948-2013Class II

Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4)...

Name: Z-1948-2013 Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4)...
Creator: Ortho-Clinical Diagnostics
Published: 2013-06-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-06-06 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes... on 2013-06-06. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement". 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-1948-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Posted: 2015-06-26
Terminated: 2018-05-17
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 6, 2013 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that an OCD trained service personnel will contact them and schedule a replacement of the CM/RT wear pads. OCD requested customers to complete and return the enclosed Confirmation of Receipt form no later than June 17, 2013. Customers are asked to place a copy of the notification by each VITROS System in their facility. Foreign affiliates were notified by email on June 6, 2013 of the issue and instructed to notify their consignees of the issue and actions. If you have any questions or need additional information, please call Customer Technical Services at 1-800-421-3311.
Distribution: Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain.
Product codes and lots: Serial Numbers: 1) J34000102 through J34002323, 2) 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001633, 34001668, 34001809, 34001840, 34001850, 34001897, 3) J46000108 through J46000312, 4) J56000110 through J56001779.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1948-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1948-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09

Product code JJE

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)