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Terminated

RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

FDA Recall Z-1045-2009 · Posted 2009-04-06

Recalling FirmImmuno Concepts Inc
Recall StatusTerminated
Product CodeLLL
Date Initiated2008-11-25
Date Terminated2009-11-17
Product Quantity25 kits

Reason for Recall

In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.

Firm Action

The firm has issued telephone calls, e-mails and notification letters to its consignees.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution including USA, Australia, England, Sweden and Austria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935129RELISA ENA ANTIBODY SCREENING TEST SYSTEMImmuno Concepts, Inc. · 1994-01-31

Official Source

View FDA Recall →

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

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