ID-DiaCell, ID-DiaPanel, ID-Panel P & ID-DiaCell ABO (2020-12-24)
- Starting date:
- December 24, 2020
- Posting date:
- January 7, 2021
- 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-74713
Last updated: 2021-01-07
Affected Products
A. ID-DiaCell I-II 2x10 ml
B. ID-DiaCell I-II-III 3x10 ml
C. ID-DiaPanel (1-11) 11x4 ml
D. ID-Panel P (Set of 11 vials) 11x4 ml
E. ID-DiaCell ABO (A1,B) 2x10 ml
Reason
Two phenomena might be observed:
The first phenomenon concerns nonspecific reactions primarily observed on QC samples but also with patient samples and eluates. Doubtful reactions or in some cases false positive reactions may occur randomly between batches and within a same batch. This phenomenon can appear with both manual and all automated methods.
The second phenomenon concerns insufficient homogenization of the red blood cells within the vials when stored on-board of the IH-500 or the IH-1000, and when the remaining volume is less than or equal to 2ml. The lack of homogenization can lead to the dispensing of low-concentrated reagent red blood cells into the wells of the ID-cards.
Affected products
A. ID-DiaCell I-II 2x10 ml
Lot or serial number
45151751
45151771
Model or catalog number
3613
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
B. ID-DiaCell I-II-III 3x10 ml
Lot or serial number
45184641
45184821
Model or catalog number
4310
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
C. ID-DiaPanel (1-11) 11x4 ml
Lot or serial number
45161031
45161051
Model or catalog number
4114
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
D. ID-Panel P (Set of 11 vials) 11x4 ml
Lot or serial number
45171031
45171051
Model or catalog number
4214
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
E. ID-DiaCell ABO (A1,B) 2x10 ml
Lot or serial number
45092801
45092821
Model or catalog number
3624
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND