Dade Behring recalls the D-Dimer PLUS Testkits
2004.12.16
Product group In-vitro diagnostics
Reference 02716/04
Dade Behring settles a recall of D-Dimer PLUS Testkit lot numbers 544454, 544439 to 544453 and 544455 to 544458. lot number 544454 does not demonstrate acceptable stability after reconstitution. Therefore, customers were advised by the manufacturer to discontinue use and discard remaining inventory. lot numbers 544439 to 544453 and 544455 to 544458 showed a stability at 2-8oC of D-Dimer PLUS Reagent and D-Dimer PLUS Accelerator after reconstitution and storage in closed vials which is reduced from 5 days to 2 days. Furthermore, the stability on board of certain instruments is reduced from 48 hours to 24 hours. Customers were advised accordingly by the customer.
Dade Behring recalls the D-Dimer PLUS Testkits , Download_VeroeffentlichtAm_EN