Health product recall

HemosIL Factor XII Deficient Plasma (2017-07-17)

Starting date:
July 17, 2017
Posting date:
March 13, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66136

Affected products

HEMOSIL FACTOR XII DEFICIENT PLASMA

Reason

HemosIL Factor XII Deficient Plasma are not meeting their labeled on-board instrument stability claim for the ACL Top Family and ACL Top Family 50 Series of 24 hours at 15 C, the affected lots numbers are only stable for 2 hours on-board the instrument. Consequently, there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.

Affected products

HEMOSIL FACTOR XII DEFICIENT PLASMA

Lot or serial number
  • N0261273
  • N0556645
  • N0764104
  • N0958653
  • N1065905
Model or catalog number

20011200

Companies
Manufacturer

Instrumentation Laboratory Co.

180 Hartwell Road

Bedford

01730-2443

UNITED STATES