STROMATOLYSER-4DS System (2019-07-15)
- Starting date:
- July 15, 2019
- Posting date:
- August 9, 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-70637
Last updated: 2019-08-09
Affected Products
A. STROMATOLYSER-4DS
B. RET-SEARCH II
C. POCH-PACK D
D. POCH-PACK L
Reason
Reason for Field Correction - Sysmex Reagents America, Inc. (SRA) identified that some Sysmex hematology reagent labels either lacked the text "Reagent Code" beside the barcode or were missing the hyphens that separate the date fields for the expiration date which is inconsistent with the manufacturing Instruction Manual.
Affected products
A. STROMATOLYSER-4DS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
FFS-800A
Companies
- Manufacturer
-
Sysmex Reagents America
Two Sysmex Way
Mundelein
60060
Illinois
UNITED STATES
B. RET-SEARCH II
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
RED-700A
Companies
- Manufacturer
-
Sysmex Reagents America
Two Sysmex Way
Mundelein
60060
Illinois
UNITED STATES
C. POCH-PACK D
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PPD-300A
Companies
- Manufacturer
-
Sysmex Reagents America
Two Sysmex Way
Mundelein
60060
Illinois
UNITED STATES
D. POCH-PACK L
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PPL-200A
Companies
- Manufacturer
-
Sysmex Reagents America
Two Sysmex Way
Mundelein
60060
Illinois
UNITED STATES