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Terminated

BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

FDA Recall Z-0574-05 · Posted 2005-03-08

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJQ
Date Initiated2005-02-15
Date Terminated2006-05-10

Reason for Recall

The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

Firm Action

Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953710ELX808 AUTOMATED MICROPLATE READERSBio-Tek Instruments, Inc. · 1995-10-25

Official Source

View FDA Recall →

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

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