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Terminated

Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.

FDA Recall Z-0672-05 · Posted 2005-04-06

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLLL
Date Initiated2004-04-20
Date Terminated2006-07-22
Product Quantity29

Reason for Recall

An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.

Firm Action

Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.

Root Cause

Other

Distribution Pattern

CT, FL, NY, WA, TX, AR, TN, CANADA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944505DIASTAT ENA SINGLE WELL SCREEN KITShield Diagnostics, Ltd. · 1994-11-21

Official Source

View FDA Recall →

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

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