FDA Device Recall Z-0032-2014: Bio-Rad Laboratories

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2014.

Recall Res Number

Z-0032-2014

Recalling Firm / Manufacturer

Bio-Rad Laboratories

FEI Number

3008272466

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-08-20

Date Posted

2013-10-21

Date Terminated

2013-11-13

Product Code

LOM

Event Number

66293

Product Quantity

23 kits

Product Description FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

Reason for Recall The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.

Action Details BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.

Distribution Pattern US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA

Code Information / Serial Numbers Lot 122822

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
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Medical Device Recall: Z-0032-2014

Recall Parameters & Description

Related Establishments / Registrations

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