Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative a
FDA device recall Z-0048-2012 · posted 2011-10-14 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OOI
- Quantity affected
- 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, Bulg
- Date initiated
- 2011-09-08
- Date posted
- 2011-10-14
- Date terminated
- 2016-03-08
- Location
- Des Plaines, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705) | Abbott Molecular, Inc. | 2010-05-28 |