Z-0138-2011

ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in...

Name: Z-0138-2011 ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in...
Creator: Instrumentation Laboratory Co.
Published: 2010-08-13
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2010-08-13 / Terminated / root cause: software

FDA source

Instrumentation Laboratory Co. began a recall of ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis... on 2010-08-13. The reason FDA records is "Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0138-2011
Status: Terminated
Initiated: 2010-08-13
Posted: 2010-10-25
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
Root cause tag: software
FDA root cause: Software design
Action: Instrumentaion Laboratory notified the US Distributor/Canada via BCI Service Modification Notice (#10793) on August 13, 2010. The Mandatory software upgrade to Verison V4.3.0 in the United States and Canada will be conducted by BCI service representatives and tracked through the distributor, Beckman Coulter (BCI). International Affiliates/Dealers: Worldwide Regulatory Notices were e-mailed to IL international affiliates and dealers, notifying them of the mandatory software upgrade, providing issue description and a risk summary and the support. The upgrades were to be handled through the local representatives.
Quantity in commerce: 609 units
Distribution: Worldwide Distribution, USA and Canada
Product codes and lots: Serial Number range: 06020101-10030659

Product code GKP

K091980Class IIAcl Top 700 LasInstrumentation Laboratory CO / cleared 2009-09-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)