Health product recall

Panocell-10, Ficin Treated and Panocell-16 (2018-12-26)

Starting date:
December 26, 2018
Posting date:
January 11, 2019
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-68750

Affected products

  1. Panocell-10, Ficin Treated
  2. Panocell-16

Reason

Immucor Inc. is issuing a product recall notification regarding the Jsa antigen typing for donor D2070, vial #4 of lots 34457-E and 41531. Additional DNA testing of donor D2070 has confirmed the donor as Js(a+). This donor was previously typed as Js(a-).

Affected products

A. Panocell-10, Ficin Treated

Lot or serial number

Lot # 34457-E, Exp: 2018-10-26

Model or catalog number

0002385

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30071

Georgia

UNITED STATES

B. Panocell-16

Lot or serial number

Lot # 41531, Exp: 2018-12-14

Model or catalog number

0002332

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30071

Georgia

UNITED STATES