Health product recall

IMMULITE & 1000 & 2000 System - ACTH Assay (2020-03-27)

Starting date:
March 27, 2020
Posting date:
April 17, 2020
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-72821



Last updated: 2020-04-21

Affected Products

A. IMMULITE System - ACTH Assay

B. IMMULITE 2000 System  -  ACTH Assay

C. IMMULITE 1000 System - ACTH Assay

Reason

Recall due to upcoming instructions for use (IFU) updates for the IMMULITE/IMMULITE 1000 and IMMULITE 2000/2000 XPI ACTH assays.

Affected products

A. IMMULITE System - ACTH Assay

Lot or serial number

278

279

281

301

302

Model or catalog number

LKAC1

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM


B. IMMULITE 2000 System  -  ACTH Assay

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

L2KAC2

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM


C. IMMULITE 1000 System - ACTH Assay

Lot or serial number

278

279

281

301

302

Model or catalog number

LKAC1

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM