qUAntify Control and qUAntify Plus Control (2018-06-18)
- Starting date:
- June 18, 2018
- Posting date:
- June 29, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67142
Affected products
- qUAntify Control
- qUAntify Plus Control
Reason
Bio-rad has found that values for blood and ketones can gradually decrease, while pH values can gradually increase over the course of the lifespan of these product lots.
Affected products
A. qUAntify Control
Lot or serial number
- 78770
- 78780
Model or catalog number
- 975
- 975X
Companies
- Manufacturer
-
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES
B. qUAntify Plus Control
Lot or serial number
- 79610
- 79611
- 79612
- 79620
- 79621
- 79622
- 79630
- 79631
- 79632
- 79640
- 79641
- 79642
- 79650
- 79651
- 79652
- 79660
- 79662
- 80510
- 80520
- 80530
- 80540
- 80550
- 80560
Model or catalog number
- 962
- 962X
- 963
- 964
- 995
- 995X
Companies
- Manufacturer
-
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES