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Health product recall

Panocell-16/20 and Capture-R Ready ID (2016-01-15)

Starting date:
January 15, 2016
Posting date:
February 1, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-56912

Affected Products

  1. Panocell-16
  2. Capture-R Ready-ID
  3. Capture-R Ready-ID Extend II
  4. Panocell-20

Reason

Immucor has received reports of unexpected positive reactivity when testing donor n3512 with anti-V. The initial investigation into these reports has confirmed that donor n3512 is V+ when tested with additional sources of anti-V. Donor n3512 will be labeled as V+ going forward.

Affected products

  1. Panocell-16

Lot or serial number
  • 39330 expiry: 2015-12-04
Model or catalog number
  • 2332
Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30091-5625

Georgia

UNITED STATES



B. Capture-R Ready-ID

Lot or serial number

ID286 expiry: 2016-03-22

ID287 expiry: 2016-03-22

Model or catalog number

0066204

0066214

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30091-5625

Georgia

UNITED STATES



C.Capture-R Ready-ID Extend II

Lot or serial number

DN074 expiry: 2014-07-29

Model or catalog number

0006456

0006457

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30091-5625

Georgia

UNITED STATES



D. Panocell-20

Lot or serial number

14052 expiry: 2015-06-12

23160 expiry: 2015-08-14

47436 expiry: 2016-01-29

Model or catalog number

5020

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30091-5625

Georgia

UNITED STATES