Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma

FDA device recall Z-1043-2012 · posted 2012-02-16 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

GGW

Quantity affected

24,672 Kits

Distribution

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, O

Date initiated

2011-12-19

Date posted

2012-02-16

Date terminated

2014-04-03

Location

Newark, DE

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