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Terminated

Access Immunoasay Systems Digoxin Reagent

FDA Recall Z-0576-05 · Posted 2005-03-08

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeKXT
Date Initiated2005-02-23
Date Terminated2005-09-02
Product Quantity4352 domestically.

Reason for Recall

Variability in results on Patient and QC results of 20-25%, high and low.

Firm Action

Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925802ACCESS DIGOXIN ASSAYBio-Rad Laboratories, Inc. · 1993-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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