Elecsys 2010 Analyzer Software version 06-07 recallZ-1218-2012 · Roche Diagnostics Operations, Inc. · initiated Jan 31, 2012
Terminated All recalls posted in March 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1218-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 31, 2012
- Posted by the FDA
- Mar 16, 2012
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- Software version 06-07 was installed on Elecsys 2010 analyzers at 13 accounts.
- Product code
- JJE
- FDA submissions
- K961481
- 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland
Product description
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.
Code information (models, lots, serial numbers)
Elecsys 2010 Analyzer Rack: 11804014001 Elecsys 2010 Analyzer Disk: 11568248001 Software version 06-07: 06526080001, 06569668001
Other devices under the same FDA submission
2 devices cleared under K961481 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- cobas e 411 Immunoassay Analyzer 04775201001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE685 reports
- cobas e 411 Immunoassay Analyzer 04775279001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE533 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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