Recall Z-1218-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
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.
| Date | Mar 16, 2012 (initiated Jan 31, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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 re |
| Quantity | 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961481 | ELECSYS 2010 ANALYZER Boehringer Mannheim Corp., Jun 14, 1996 |