FDA Device Recall Z-0009-06: Beckman Coulter Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-06.

Recall Res Number

Z-0009-06

Recalling Firm / Manufacturer

Beckman Coulter Inc

FEI Number

2050012

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-09-06

Date Posted

2005-10-06

Date Terminated

2012-01-26

Product Code

JJE

Event Number

33453

Product Quantity

868

Product Description Synchron LX Systems Version 4.5 Operating Software

Reason for Recall Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.

Action Details Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.

Distribution Pattern Nationwide and Canada

Code Information / Serial Numbers Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database).

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Medical Device Recall: Z-0009-06

Recall Parameters & Description

Related Establishments / Registrations

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