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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 ANA Screen on the BioPlex 2200 MultiAnalyte Detection System

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 Class 2 Device Recall BioPlex 2200 ANA Screen on the BioPlex 2200 MultiAnalyte Detection Systemsee related information
Date Initiated by FirmNovember 13, 2007
Date PostedJune 11, 2008
Recall Status1 Terminated 3 on May 23, 2011
Recall NumberZ-1159-2008
Recall Event ID 45875
510(K)NumberK043341 
Product Classification ANA in-vitro diagnostic test kit - Product Code LKJ
ProductBIOPLEX 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.
Code Information Eleven (11) Lots, as follows: Lot Numbers: 931396 Exp. 9/30/06; 935424 Exp. 3/31/07; 941886 Exp. 3/31/07; 935682 Exp. 4/30/07; 937351 Exp. 6/30/07; 941343 Exp. 3/31/08; 941428 Exp. 4/30/08; 945246 Exp. 9/30/08; 945875 Exp. 12/31/08; 945248 Exp. 10/31/08 and 945875 Exp. 12/31/08 ****       
Recalling Firm/
Manufacturer
Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information ContactScott J. Dennis
425-498-1709
Manufacturer Reason
for Recall
False negative results due to reagent packs exhibiting low signal.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce8,804 kits
DistributionWorldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LKJ
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