Dade(R) Actin(R) FSL Activated PTT Reagent recallZ-1073-2013 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 11, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Unknown/Undetermined by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1073-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 11, 2013
- Posted by the FDA
- Apr 9, 2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,083
- Product code
- GGW
- FDA submissions
- K863594
- 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 description
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K863594 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dade® Actin® FSL Activated PTT Reagent 10445714Siemens Healthcare Diagnostics Products GmbH · TEST, TIME, PARTIAL THROMBOPLASTIN32 reports
- Dade® Actin® FSL Activated PTT Reagent 10445713Siemens Healthcare Diagnostics Products GmbH · TEST, TIME, PARTIAL THROMBOPLASTIN6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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