Z-0048-2012

Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in...

Name: Z-0048-2012 Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in...
Creator: Abbott Molecular
Published: 2011-09-08
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2011-09-08 / Terminated / root cause: software

FDA source

Abbott Molecular began a recall of Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic... on 2011-09-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0048-2012
Status: Terminated
Initiated: 2011-09-08
Posted: 2011-10-14
Terminated: 2016-03-08
Recalling firm: Abbott Molecular, Inc.
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.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: 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 tag: software
FDA 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 in commerce: 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
Product codes and lots: catalog #09K15-01, all software versions are affected.

Product code OOI

K092705Class IIAbbott M2000sp and Abbott M2000rt, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Abbott Molecular, Inc. / cleared 2010-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)