IH-500
Brand(s)
Last updated
Summary
Product
IH-500
Issue
Medical devices - Performance issue
What to do
Contact BIO-RAD LABORATORIES (CANADA) LTD. if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| IH-500 | All lots. | 001500 |
| Diaclon Abo/D+Reverse-Group | All lots. | 001236 001235 001234 001237 |
| Diaclon Anti-N | All lots. | 00711 |
| Diaclon Abd Confirmation For Donors | All lots. | 001135 001136 001134 001133 |
| Diaclon Rh-Subgroup+K | All lots. | 002127 002125 002126 002124 |
| Diaclon Anti-M | All lots. | 007011 |
| Diaclon Abd Confirmation For Patients | All lots. | 001255 001256 001254 001257 |
Issue
In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e".
Recall start date: September 23, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Diamed Gmbh
Pra Rond 23, Cressier Fr, Switzerland, 1785
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72020
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