—#106986

Product

Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.

FDA product code: GGW — Test, Time, Partial Thromboplastin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K863594
Affected lot / code info: Catalog number B4219-1J, lot numbers 537360, 537374 and 547301; catalog number B4219-1, lot numbers 537360A, 537366, 537374A, 547301A, and 547306; catalog number B4219-2J, lot numbers 534362 and 537365; and catalog number B4219-2, lot numbers 537362A and 537365A.

Why it was recalled

The listed lots of Dade(R) Actin(R) FSL Reagent 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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Siemens sent an Urgent Field Safety Notice letter dated December 2011 to all customers of the affected lots. The letter identified the product, description of problem, and actions to be taken by the user. Dade Actin FSL customers were instructed to exercise one of two options: 1) If customers would like to continue working with their Dade(R) Actin FSL reagent lot (if one of the impacted lots) they must verify on a regular basis (monthly) that their therapeutic range is still valid, e.g. by using a Heparin containing control. In the case that it is not valid, they are to adjust their existing therapeutic range or establish a new one. 2) If customers decide not to continue working with the Dade(R) Actin(R) reagent lot (if one of the impacted lots) they are to contact their Siemens representative at 1-800-242-3233, option 5, for a replacement lot. Once they have established a new normal, therapeutic, and quality control ranges, they are to discard the remainder of the old lot. Customers were advised to complete the response form included to confirm receipt of Safety Notice and fax back to (302) 631-8467. If you have any questions or concerns, please contact the Technical Solutions Center at 1-800-242-3233, option 1.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, Oman, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.

Timeline

Recall initiated: 2011-12-19
Posted by FDA: 2012-02-16
Terminated: 2014-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.