Z-1073-2013Class II

Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial...

Name: Z-1073-2013 Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-03-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-03-11 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT) on 2013-03-11. FDA classified it as Class II and gives the reason as "Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1073-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Posted: 2013-04-09
Terminated: 2013-12-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Product code: GGW Test, Time, Partial Thromboplastin
Reason for recall: Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated February 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The safety notice instructed consignees to discontinue use of the affected lots and discard any remaining inventory. Contact the firm at 1-800-242-3233, option 1 for questions about this notice.
Quantity in commerce: 13,083
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
Product codes and lots: Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1073-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1073-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-09

Product code GGW

K863594Class IIActin Fsl Activated Ptt ReagentAmerican Dade / cleared 1986-10-17

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)