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Terminated

Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.

FDA Recall Z-1218-2012 · Posted 2012-03-16

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-01-31
Date Terminated2012-09-06
Product QuantitySoftware version 06-07 was installed on Elecsys 2010 analyzers at 13 accounts.

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

Firm Action

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

Distribution Pattern

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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961481ELECSYS 2010 ANALYZERBoehringer Mannheim Corp. · 1996-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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