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Cell-Chex (2014-09-15)
- Starting date:
- September 15, 2014
- Posting date:
- October 2, 2014
- 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-41637
Recalled Products
Cell-Chex
Reason
Error on the assay for Cell-Chex control lot 4244. Mononuclear and polymorphonuclear percentages in the white blood count differential section are inverted for L1-UC, L1-CC and L2. Correct mononuclear value for all levels should be 26% and correct polymorphononuclear value for all levels should be 74%.
Affected products
Cell-Chex
Lot or serial number
4244
Model or catalog number
212420
212424
212425
212429
212430
212431
212432
Companies
- Manufacturer
-
Streck
7002 South 109th Street,
Omaha
68128
Nebraska
UNITED STATES