Health product recall

VITROS Chemistry Products 7% BSA & Urine Electrolyte Diluent (UED) (2019-10-21)

Starting date:
October 21, 2019
Posting date:
November 15, 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-71603

Last updated: 2019-11-15

Affected Products

  1. VITROS Chemistry Products 7% BSA
  2. VITROS Chemistry Products Urine Electrolyte Diluent (UED)

Reason

Ortho Cinical Diagnostics determined that VITROS 7% BSA and VITROS  Urine Electrolyte Diluent (UED) do not meet the current OAS time of 7 Days when stored on the Vitros 250/350 system in a 2ml cup only.

Affected products

  1. VITROS Chemistry Products 7% BSA

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

8262487

Companies
Manufacturer
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES

B. VITROS Chemistry Products Urine Electrolyte Diluent (UED)

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

111 0352

Companies
Manufacturer
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES