Z-0594-2007

Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and...

Name: Z-0594-2007 Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and...
Creator: Inverness Medical Professional Diagnostics
Published: 2007-02-15
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2007-02-15 / Terminated

FDA source

Inverness Medical Professional Diagnostics began a recall of 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... on 2007-02-15. The reason FDA records is "Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0594-2007
Status: Terminated
Initiated: 2007-02-15
Posted: 2007-03-13
Terminated: 2007-05-08
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: 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.
Product code: GHH Fibrin Split Products
Reason for recall: Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
FDA root cause: Other
Action: Recall notification letters were sent to all customers on 2/14/07 by first class mail.
Quantity in commerce: 382 kits
Distribution: Worldwide, including USA, Puerto Rico, and Canada.
Product codes and lots: Kit lot number: PX018A Test device batch number: 682-024 Catalog Number: 6100KVC Expiration date: 3/2008

Product code GHH

K993276Class IISimplify D-Dimer, Model Dcgk1Agen Biomedical , Ltd. / cleared 1999-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)