FDA Device Recall Z-0042-06: Abbott Laboratories Medisense Products

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-06.

Recall Res Number

Z-0042-06

Recalling Firm / Manufacturer

Abbott Laboratories Medisense Products

FEI Number

3002803444

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-06-07

Date Posted

2005-10-21

Date Terminated

2006-05-17

Product Code

NBW

Event Number

33301

Product Quantity

N/A

Product Description FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Reason for Recall User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

Action Details The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.

Distribution Pattern Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.

Code Information / Serial Numbers All lot numbers beginning with R and all lot numbers T-G158-62981 and below are included.

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Medical Device Recall: Z-0042-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer