Z-1127-2007

Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

Name: Z-1127-2007 Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
Creator: Instrumentation Laboratory Co.
Published: 2007-06-19
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2007-06-19 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000 on 2007-06-19. The reason FDA records is "ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1127-2007
Status: Terminated
Initiated: 2007-06-19
Posted: 2007-08-07
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.
FDA root cause: Other
Action: Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.
Quantity in commerce: 94
Distribution: Nationwide.
Product codes and lots: Serial numbers prior to 07060782

Product code GKP

K063679Class IIAcl TopInstrumentation Laboratory CO / cleared 2007-01-12

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)