Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/N

FDA device recall Z-1028-2013 · posted 2013-04-01 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.

Action taken

Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.

Root cause

Process control

Status

Terminated

Product code

OOI

Quantity affected

189 units

Distribution

Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.

Date initiated

2013-03-01

Date posted

2013-04-01

Date terminated

2014-06-04

Location

Indianapolis, IN

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