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 it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.

Recall number

Z-0048-2012

Recalling firm

Abbott Molecular

Product

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 it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.

Status

Terminated

Initiated

2011-09-08

Posted

2011-10-14

Terminated

2016-03-08

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 matter.

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 Republic, Dem. Rep. of the Congo, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Gabon, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Libya, Lithuania, Malawi, Malaysia, Mali, Mauritius, Mexico, Moldova, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Venezuela, Vietnam, Zambia and Zimbabwe

Lot, serial or model codes

catalog #09K15-01, all software versions are affected.

510(k) numbers

["K092705"]

PMA numbers

not on file

Product code

OOI

Firm FEI

3005248192

Firm city

Des Plaines

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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