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Terminated

ICON DS hCG, an in-vitro diagnostic. Part number 44025.

FDA Recall Z-0706-03 · Posted 2003-04-02

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJHI
Date Initiated2003-02-20
Date Terminated2003-09-25
Product Quantity12,804

Reason for Recall

Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.

Firm Action

Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)ACON Laboratories, Inc. · 1999-12-01

Official Source

View FDA Recall →

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

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