Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qua

FDA device recall Z-1218-2012 · posted 2012-03-16 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not bel

Action taken

Roche sent an Urgent Medical Device Correction letter dated January 31, 2012, via UPS Ground (receipt required) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: use one of the workarounds outlined in this Urgent Medical Device Correction (UMDC) if you are running an automatic dilution on an Elecsys 2010 analyzer with software version 06-07; complete the attached faxback form (4600-00-0112) and fax it to 1-888-912-8460; and file this UMDC for future reference. For questions regarding this recall call 1-800-428-2336.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

Software version 06-07 was installed on Elecsys 2010 analyzers at 13 accounts.

Distribution

Worldwide Distribution - USA including NY, GA, DE, SD, WI, ME, OR, IA, AND CA and the countries of Austria, Cyprus, Czech Republic, Estonia, France, Germany,Greece, Hungary, Iceland, Italy, Latvia, No

Date initiated

2012-01-31

Date posted

2012-03-16

Date terminated

2012-09-06

Location

Indianapolis, IN

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