Dade Behring Inc. Recalls
Showing 1-5 of 5 recalls
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
sample may exhibit falsely high results
On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.
Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.
Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
prolonged aPTT results
The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
positive control shows weak agglutination reaction
The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Reports of false negative results on Sysmex Coagulation System.
On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.