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Terminated

Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.

FDA Recall Z-0065-2008 · Posted 2007-10-31

Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeLOM
Date Initiated2007-09-05
Date Terminated2007-11-15
Product Quantity46

Reason for Recall

Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.

Firm Action

On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.

Root Cause

Error in labeling

Distribution Pattern

Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.

Official Source

View FDA Recall →

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

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