Z-0304-06

Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100

Name: Z-0304-06 Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
Creator: Dade Behring , Inc.
Published: 2005-09-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-09-23 / Terminated

FDA source

Dade Behring , Inc. began a recall of Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100 on 2005-09-23. The reason FDA records is "prolonged aPTT results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0304-06
Status: Terminated
Initiated: 2005-09-23
Posted: 2005-12-23
Terminated: 2006-05-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
Product code: GGW Test, Time, Partial Thromboplastin
Reason for recall: prolonged aPTT results
FDA root cause: Other
Action: The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
Quantity in commerce: 4176 packs
Distribution: The products were shipped to medical facilities and/or laboratories nationwide.
Product codes and lots: Lot number 527263 exp 2/3/06

Product code GGW

K811589Class IIActin Fs Activated Ptt ReagentAmerican Dade / cleared 1981-07-16

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)