Panocell-10 Ficin-Treated (2015-11-19)

Starting date:

November 19, 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-56206

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  Reason
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  Affected products

Affected Products

Panocell-10 Ficin-Treated

Reason

Immucor Inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a market withdrawal of cell 4 included in the Panocell-10 Ficin-treated, Lot 38324-E. Cell 4 (DONORD1377) on this panel, is listed as S+S- on the master list. In response to a report of unexpected negative reactivity on untreated cell 4, we have reproduced the customer's reported results. Cell 4 has demonstrated reactivity varying from negative to 3+ using different sources of anti-S. Cell 4 is one of four S+ red blood cells on this panel: cells 2, 7 and 9 are also s+. Cell 4 is the only s+s- cell on this panel.

Affected products