cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.

FDA device recall Z-2203-2016 · posted 2016-07-13 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

Reason for recall

Kit labeled with the incorrect expiration date.

Action taken

An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

OCC

Quantity affected

194 distributed kits

Distribution

Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.

Date initiated

2016-05-17

Date posted

2016-07-13

Date terminated

2017-02-01

Location

S Branchburg, NJ

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