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Terminated

BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

FDA Recall Z-1159-2008 · Posted 2008-06-11

Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeLKJ
Date Initiated2007-11-13
Date Terminated2011-05-23
Product Quantity8,804 kits

Reason for Recall

False negative results due to reagent packs exhibiting low signal.

Firm Action

On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043341BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc. · 2005-10-27

Official Source

View FDA Recall →

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

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