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Class 2 Device Recall BioTek Gen5CL Microplate Data Collection and Analysis Software |
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Date Initiated by Firm |
March 12, 2009 |
Date Posted |
September 18, 2009 |
Recall Status1 |
Terminated 3 on May 18, 2015 |
Recall Number |
Z-2223-2009 |
Recall Event ID |
52218 |
Product Classification |
Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
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Product |
BioTek Gen5CL Microplate Data Collection and Analysis Software.
Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.
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Code Information |
Software versions 1.07 and lower. |
Recalling Firm/ Manufacturer |
BioTek Instruments, Inc. Highland Park/Box 998 Winooski VT 05404
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For Additional Information Contact |
Lenore Buehrer 802-655-4040
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Manufacturer Reason for Recall |
Software design allowed false negatives to be read when wells are dark.
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FDA Determined Cause 2 |
Software design |
Action |
BioTek Instruments, Inc. issued a "Product Recall Notification" dated March 13, 2009 information customers of the affected product. Follow-up letters with software installation instructions were sent March 25, 2009.
For further information, contact BioTek Instruments, Inc. at 1-888-451-5171 extension 405. |
Quantity in Commerce |
13 |
Distribution |
Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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