Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009
FDA device recall Z-2201-2011 · posted 2011-05-19 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
- Action taken
- Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 272
- Distribution
- Nationwide Distribution -- Including Puerto Rico.
- Date initiated
- 2010-07-19
- Date posted
- 2011-05-19
- Date terminated
- 2011-08-25
- Location
- Redmond, WA
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Related 510(k) clearances
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| MONOLISA ANTI-HAV IGM EIA (K092353) | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| SERAQUEST RUBELLA IGG (K961053) | Quest Intl., Inc. | 1996-09-04 |