Recall Z-0048-2012 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular
Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01 The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as
| Date | Oct 14, 2011 (initiated Sep 8, 2011) |
| Status | Terminated |
| Reason | The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the final results, which could cause an inval |
| Root cause | Software design |
| Action | Abbott Molecular Inc. sent a Field Correction Recall letter dated September 8, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until an upgrade to your m2000rt software can be installed. Abbott Molecular estimates that this software version will be available the first quarter of 2012. Please complete the enclosed reply sheet and fax it to (847) 775-6728 at your earliest convenience to acknowledge receipt. We appreciate your assistance in this |
| Quantity | 926 units |
| Distribution | Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belgium, Benin, Bolivia, Bosnia and Herzegovia, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Repu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc., May 28, 2010 |