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Terminated

Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.

FDA Recall Z-0594-2007 · Posted 2007-03-13

Recalling FirmInverness Medical Professional Diagnostics
Recall StatusTerminated
Product CodeGHH
Date Initiated2007-02-15
Date Terminated2007-05-08
Product Quantity382 kits

Reason for Recall

Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

Firm Action

Recall notification letters were sent to all customers on 2/14/07 by first class mail.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Puerto Rico, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993276SIMPLIFY D-DIMER, MODEL DCGK1Agen Biomedical , Ltd. · 1999-12-14

Official Source

View FDA Recall →

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

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