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Terminated

Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

FDA Recall Z-0733-2007 · Posted 2007-04-10

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeDKZ
Date Initiated2007-02-12
Date Terminated2008-02-04
Product Quantity177 Kits

Reason for Recall

The product may produce a faint line which could be interpreted as a false negative test result .

Firm Action

The firm intends to contact its subsidiary distributors and sales staff via Fax (Feb 12, 2007) and phone call. In addition, the recall notification will be posted on the firm's intranet site. Customers are instructed to destroy recalled product following standard laboratory practices.

Root Cause

Other

Distribution Pattern

Worldwide distribution --- USA and countries of Australia and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031759ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARDACON Laboratories, Inc. · 2003-08-04

Official Source

View FDA Recall →

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

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