ALLSET GOLD SSP (2015-04-15)

Starting date:

April 15, 2015

Posting date:

May 8, 2015

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-53287

• Reason
• Affected products

Recalled Products

A. ALLSET GOLD DPB1 HIGH RES SSP
B. DPB1 SSP UNITRAY W/TAQ 12 TEST, DPB1 SSP UNITRAY 12 TESTS

Reason

One complaint regarding this issue has been received. One customer complaint (PR184220) was recorded. A customer reported that the reactivity for lanes 13, 27, 30, 39 and 40 was negative for the DPB1*99:01 allele when the labeling of the DPB1 SSP Unitray 12 tests kit (451606D) indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping a DPB1*99:01 allele (population frequency < 0.01%) as a DPB1*39:01 allele. After investigation, it was determined that the DPB1 SSP Unitray with Taq 12 tests kit (451616D) and the Allset Gold DPB1 High RES SSP kit (54070D) are also affected by the labeling issue since they contain the same primer present in the DPB1 SSP Unitray 12 tests kit (451606d). Life technologies confirmed the issue on 11 March 2015.

Affected products